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Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00012298
Recruitment Status : Terminated (Trial completed prematurely.)
First Posted : January 27, 2003
Results First Posted : December 17, 2015
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: rituximab
Biological: yttrium Y 90 ibritumomab tiuxetan
Biological: indium In 111 ibritumomab tiuxetan
Biological: oprelvekin
Biological: filgrastim
Enrollment 81
Recruitment Details  
Pre-assignment Details Phase I is a series of three single-arm trials: Trial 1 will determine the Y2B8 MTD without growth factors, Trial 2 will test the regimen with G-CSF and IL-11 added to the treatment, and Trial 3 tests different levels of IL-11 in the regimen.
Arm/Group Title Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6 Treatment : Phase II (Dose Level 6)
Hide Arm/Group Description

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Period Title: Overall Study
Started 11 7 9 4 5 6 39
Completed 11 7 9 4 5 6 39
Not Completed 0 0 0 0 0 0 0
Arm/Group Title Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6 Treatment : Phase II (Dose Level 6) Total
Hide Arm/Group Description

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Total of all reporting groups
Overall Number of Baseline Participants 11 7 9 4 5 6 39 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 7 participants 9 participants 4 participants 5 participants 6 participants 39 participants 81 participants
60
(39 to 70)
56
(31 to 65)
52
(37 to 70)
51
(30 to 67)
46
(42 to 60)
59
(28 to 62)
58
(36 to 76)
58
(28 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 7 participants 9 participants 4 participants 5 participants 6 participants 39 participants 81 participants
Female
4
  36.4%
4
  57.1%
2
  22.2%
2
  50.0%
3
  60.0%
1
  16.7%
17
  43.6%
33
  40.7%
Male
7
  63.6%
3
  42.9%
7
  77.8%
2
  50.0%
2
  40.0%
5
  83.3%
22
  56.4%
48
  59.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 7 participants 9 participants 4 participants 5 participants 6 participants 39 participants 81 participants
Saudi Arabia 0 0 0 1 0 0 0 1
Croatia 1 0 0 0 0 0 0 1
United States 10 7 9 3 5 6 39 79
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)
Hide Description

This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly.

> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event.

> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here.

Time Frame At 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD.
Arm/Group Title Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6
Hide Arm/Group Description:

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Patients receive:

Cycle 1:

50 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Overall Number of Participants Analyzed 9 6 5 4 4 6
Measure Type: Number
Unit of Measure: Patients reporting Dose-Limiting Events
0 2 0 2 0 1
2.Primary Outcome
Title Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)
Hide Description Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.
Time Frame Assessed up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.
Arm/Group Title Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6
Hide Arm/Group Description:

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Overall Number of Participants Analyzed 11 7 9 4 5 6
Measure Type: Number
Unit of Measure: participants
Grade 3+ Adverse Event 9 6 8 4 5 6
Grade 4+ Adverse Event 2 5 2 2 1 1
Grade 5 Adverse Event 0 0 0 0 0 0
3.Primary Outcome
Title Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)
Hide Description Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Forty-five patients were registered to Dose Level 6 (39 patients registered to the Phase II portion and 6 patients registered to Dose Level 6 in the Phase I portion). Of the 45 patients, 33 patients received 2 sequential doses of Y2B8 and were evaluable for this endpoint.
Arm/Group Title Treatment : Dose Level 6
Hide Arm/Group Description:

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
.45
(.28 to .64)
4.Secondary Outcome
Title Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I)
Hide Description Assessed using a correlated logistic regression model and generalized estimating equations (GEE). Covariates such as dose level and use of prophylactic cytokines may also be included in this model. A Wilcoxon test will be used to assess the equality of the distributions of the continuous levels of predicted tumor radiation from the In2B8 scans by response.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Not collected. Study team decision not to analyze this endpoint.
Arm/Group Title Treatment (Radiolabeled Monoclonal Antibody Therapy)
Hide Arm/Group Description:

Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

indium In 111 ibritumomab tiuxetan: Given IV

oprelvekin: Given subcutaneously

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I)
Hide Description Explored using a contingency table and sensitivity and specificity will be calculated using 90% exact confidence intervals.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Not collected. Study team decision not to analyze this endpoint.
Arm/Group Title Treatment (Radiolabeled Monoclonal Antibody Therapy)
Hide Arm/Group Description:

Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

indium In 111 ibritumomab tiuxetan: Given IV

oprelvekin: Given subcutaneously

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)
Hide Description Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Not collected. Study team decision not to analyze this endpoint.
Arm/Group Title Treatment (Radiolabeled Monoclonal Antibody Therapy)
Hide Arm/Group Description:

Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

indium In 111 ibritumomab tiuxetan: Given IV

oprelvekin: Given subcutaneously

filgrastim: Given subcutaneously

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Survival (Phase II)
Hide Description Estimated using the method of Kaplan-Meier.
Time Frame From registration to death due to any cause, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II portion of the study. One patient out of the 39 was deemed ineligible and was not included in survival analysis.
Arm/Group Title Treatment : Dose Level 6
Hide Arm/Group Description:

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(8.1 to NA)
[1]
Median and upper 95% confidence interval were not reached.
8.Secondary Outcome
Title Time to Disease Progression (Phase II)
Hide Description Estimated using the method of Kaplan-Meier.
Time Frame From registration to the earliest date documentation of>disease progression, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible phase II patients. One out of the 39 phase II patients was deemed ineligible.
Arm/Group Title Treatment : Dose Level 6
Hide Arm/Group Description:

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: years
2 [1] 
(1.6 to NA)
[1]
Upper 95% confidence interval was not reached.
9.Secondary Outcome
Title Tumor Response Rate (Phase II)
Hide Description Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.
Time Frame Assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible phase II patients. One of the 39 phase II patients was deemed ineligible
Arm/Group Title Treatment : Dose Level 6
Hide Arm/Group Description:

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients with response
89.5
(75.2 to 97.1)
Time Frame Baseline to 30 days post treatment, up to 3 years
Adverse Event Reporting Description Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
 
Arm/Group Title Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6 Treatment : Phase II (Dose Level 6)
Hide Arm/Group Description 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
All-Cause Mortality
Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6 Treatment : Phase II (Dose Level 6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6 Treatment : Phase II (Dose Level 6)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      5/7 (71.43%)      4/9 (44.44%)      2/4 (50.00%)      1/5 (20.00%)      1/6 (16.67%)      6/39 (15.38%)    
Blood and lymphatic system disorders               
Anemia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 2/4 (50.00%)  9 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Blood and lymphatic system disorders - Other, specify  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  12 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Cardiac disorders               
Supraventricular tachycardia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  1  1/11 (9.09%)  3 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Diarrhea  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
General disorders               
Fatigue  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
General disorders and administration site conditions - Other, specify  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Pain  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  6 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Infections and infestations               
Infections and infestations - Other, specify  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  9 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Wound infection  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Investigations               
Neutrophil count decreased  1  1/11 (9.09%)  3 4/7 (57.14%)  21 2/9 (22.22%)  6 0/4 (0.00%)  0 1/5 (20.00%)  3 1/6 (16.67%)  3 5/39 (12.82%)  18
Platelet count decreased  1  0/11 (0.00%)  0 2/7 (28.57%)  12 2/9 (22.22%)  6 2/4 (50.00%)  9 0/5 (0.00%)  0 1/6 (16.67%)  6 3/39 (7.69%)  15
White blood cell decreased  1  0/11 (0.00%)  0 1/7 (14.29%)  6 1/9 (11.11%)  3 0/4 (0.00%)  0 1/5 (20.00%)  3 1/6 (16.67%)  3 3/39 (7.69%)  12
Metabolism and nutrition disorders               
Dehydration  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Psychiatric disorders               
Confusion  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  6 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Renal and urinary disorders               
Renal and urinary disorders - Other, specify  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Reproductive system and breast disorders               
Vaginal hemorrhage  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Dyspnea  1  1/11 (9.09%)  6 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Skin and subcutaneous tissue disorders               
Erythema multiforme  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Urticaria  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Vascular disorders               
Hypotension  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Thromboembolic event  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment: Trial 1, Dose Level 1 Treatment: Trial 1, Dose Level 2 Treatment: Trial 2, Dose Level 3 Treatment: Trial 2, Dose Level 4 Treatment: Trial 3, Dose Level 5 Treatment: Trial 3, Dose Level 6 Treatment : Phase II (Dose Level 6)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/11 (100.00%)      7/7 (100.00%)      9/9 (100.00%)      4/4 (100.00%)      5/5 (100.00%)      6/6 (100.00%)      39/39 (100.00%)    
Blood and lymphatic system disorders               
Anemia  1  10/11 (90.91%)  93 7/7 (100.00%)  90 9/9 (100.00%)  57 3/4 (75.00%)  51 5/5 (100.00%)  33 6/6 (100.00%)  72 34/39 (87.18%)  330
Blood and lymphatic system disorders - Other, specify  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  18 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Febrile neutropenia  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Cardiac disorders               
Atrial flutter  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Cardiac disorders - Other, specify  1  1/11 (9.09%)  9 0/7 (0.00%)  0 4/9 (44.44%)  12 3/4 (75.00%)  15 4/5 (80.00%)  12 2/6 (33.33%)  18 9/39 (23.08%)  33
Sinus tachycardia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Supraventricular tachycardia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Ear and labyrinth disorders               
Ear pain  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Endocrine disorders               
Endocrine disorders - Other, specify  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  6 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Eye disorders               
Blurred vision  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  6 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 0/39 (0.00%)  0
Conjunctivitis  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Dry eye  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Extraocular muscle paresis  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Flashing lights  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Keratitis  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 0/39 (0.00%)  0
Watering eyes  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 0/39 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  1  3/11 (27.27%)  15 1/7 (14.29%)  3 2/9 (22.22%)  9 1/4 (25.00%)  3 2/5 (40.00%)  9 0/6 (0.00%)  0 5/39 (12.82%)  18
Bloating  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Constipation  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Diarrhea  1  1/11 (9.09%)  6 1/7 (14.29%)  3 2/9 (22.22%)  9 0/4 (0.00%)  0 1/5 (20.00%)  6 0/6 (0.00%)  0 6/39 (15.38%)  18
Dry mouth  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Duodenal obstruction  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Dyspepsia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Esophagitis  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 0/39 (0.00%)  0
Flatulence  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 2/39 (5.13%)  6
Gastrointestinal disorders - Other, specify  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Mucositis oral  1  2/11 (18.18%)  6 1/7 (14.29%)  3 2/9 (22.22%)  6 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 3/39 (7.69%)  9
Nausea  1  2/11 (18.18%)  18 5/7 (71.43%)  21 3/9 (33.33%)  9 2/4 (50.00%)  6 3/5 (60.00%)  12 2/6 (33.33%)  6 13/39 (33.33%)  48
Vomiting  1  0/11 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  6 0/4 (0.00%)  0 1/5 (20.00%)  3 1/6 (16.67%)  3 2/39 (5.13%)  6
General disorders               
Chills  1  2/11 (18.18%)  6 0/7 (0.00%)  0 1/9 (11.11%)  3 1/4 (25.00%)  3 1/5 (20.00%)  6 1/6 (16.67%)  9 6/39 (15.38%)  18
Edema limbs  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Fatigue  1  2/11 (18.18%)  9 5/7 (71.43%)  18 4/9 (44.44%)  15 1/4 (25.00%)  3 2/5 (40.00%)  12 4/6 (66.67%)  18 21/39 (53.85%)  84
Fever  1  1/11 (9.09%)  3 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 2/5 (40.00%)  6 1/6 (16.67%)  3 1/39 (2.56%)  3
General disorders and administration site conditions - Other, specify  1  2/11 (18.18%)  6 1/7 (14.29%)  3 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Injection site reaction  1  0/11 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  6 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 2/39 (5.13%)  6
Non-cardiac chest pain  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 5/39 (12.82%)  15
Pain  1  0/11 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  6 1/4 (25.00%)  3 1/5 (20.00%)  3 1/6 (16.67%)  3 2/39 (5.13%)  6
Immune system disorders               
Allergic reaction  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  9 2/6 (33.33%)  6 6/39 (15.38%)  21
Immune system disorders - Other, specify  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 0/39 (0.00%)  0
Infections and infestations               
Bladder infection  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Infections and infestations - Other, specify  1  6/11 (54.55%)  18 1/7 (14.29%)  3 3/9 (33.33%)  12 0/4 (0.00%)  0 2/5 (40.00%)  12 3/6 (50.00%)  9 11/39 (28.21%)  36
Skin infection  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 2/39 (5.13%)  6
Wound infection  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 0/39 (0.00%)  0
Injury, poisoning and procedural complications               
Bruising  1  0/11 (0.00%)  0 2/7 (28.57%)  6 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Fracture  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Investigations               
Alkaline phosphatase increased  1  3/11 (27.27%)  18 1/7 (14.29%)  6 2/9 (22.22%)  9 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 4/39 (10.26%)  15
Aspartate aminotransferase increased  1  2/11 (18.18%)  12 3/7 (42.86%)  12 1/9 (11.11%)  6 0/4 (0.00%)  0 0/5 (0.00%)  0 2/6 (33.33%)  9 3/39 (7.69%)  12
Blood bilirubin increased  1  1/11 (9.09%)  3 1/7 (14.29%)  3 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 1/6 (16.67%)  3 3/39 (7.69%)  15
Cholesterol high  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Creatinine increased  1  0/11 (0.00%)  0 2/7 (28.57%)  9 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Lymphocyte count decreased  1  0/11 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  12 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Neutrophil count decreased  1  9/11 (81.82%)  93 6/7 (85.71%)  141 9/9 (100.00%)  147 3/4 (75.00%)  105 5/5 (100.00%)  60 6/6 (100.00%)  102 32/39 (82.05%)  477
Platelet count decreased  1  10/11 (90.91%)  129 7/7 (100.00%)  117 8/9 (88.89%)  102 4/4 (100.00%)  84 5/5 (100.00%)  93 6/6 (100.00%)  126 39/39 (100.00%)  711
Weight gain  1  2/11 (18.18%)  6 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Weight loss  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 0/39 (0.00%)  0
White blood cell decreased  1  11/11 (100.00%)  135 7/7 (100.00%)  192 9/9 (100.00%)  180 3/4 (75.00%)  123 5/5 (100.00%)  72 6/6 (100.00%)  93 34/39 (87.18%)  675
Metabolism and nutrition disorders               
Anorexia  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 5/39 (12.82%)  21
Dehydration  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Hypercalcemia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 2/39 (5.13%)  6
Hyperglycemia  1  8/11 (72.73%)  33 3/7 (42.86%)  12 4/9 (44.44%)  30 2/4 (50.00%)  9 1/5 (20.00%)  6 5/6 (83.33%)  18 9/39 (23.08%)  30
Hyperkalemia  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Hyperuricemia  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Hypocalcemia  1  0/11 (0.00%)  0 1/7 (14.29%)  6 1/9 (11.11%)  3 1/4 (25.00%)  6 0/5 (0.00%)  0 2/6 (33.33%)  6 5/39 (12.82%)  15
Hypoglycemia  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Hypokalemia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Hypophosphatemia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  15 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  2/11 (18.18%)  6 1/7 (14.29%)  3 3/9 (33.33%)  12 1/4 (25.00%)  6 1/5 (20.00%)  3 3/6 (50.00%)  12 10/39 (25.64%)  33
Arthritis  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Bone pain  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 2/5 (40.00%)  6 0/6 (0.00%)  0 4/39 (10.26%)  12
Myalgia  1  1/11 (9.09%)  3 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 2/5 (40.00%)  6 3/6 (50.00%)  18 9/39 (23.08%)  30
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Treatment related secondary malignancy  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Nervous system disorders               
Dizziness  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 2/6 (33.33%)  6 0/39 (0.00%)  0
Dysgeusia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 0/39 (0.00%)  0
Extrapyramidal disorder  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 0/39 (0.00%)  0
Headache  1  0/11 (0.00%)  0 1/7 (14.29%)  6 2/9 (22.22%)  6 1/4 (25.00%)  3 1/5 (20.00%)  3 1/6 (16.67%)  3 8/39 (20.51%)  27
Neuralgia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 1/39 (2.56%)  3
Peripheral sensory neuropathy  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 4/39 (10.26%)  12
Psychiatric disorders               
Depression  1  0/11 (0.00%)  0 2/7 (28.57%)  6 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Insomnia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 0/39 (0.00%)  0
Renal and urinary disorders               
Urinary frequency  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Urinary incontinence  1  1/11 (9.09%)  6 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Urinary tract pain  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Reproductive system and breast disorders               
Erectile dysfunction  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Gynecomastia  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  6 0/5 (0.00%)  0 0/6 (0.00%)  0 2/39 (5.13%)  6
Irregular menstruation  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Allergic rhinitis  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/39 (7.69%)  12
Cough  1  2/11 (18.18%)  9 1/7 (14.29%)  3 0/9 (0.00%)  0 1/4 (25.00%)  3 2/5 (40.00%)  6 3/6 (50.00%)  9 4/39 (10.26%)  12
Dyspnea  1  0/11 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  6 0/4 (0.00%)  0 1/5 (20.00%)  3 2/6 (33.33%)  6 2/39 (5.13%)  6
Epistaxis  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 0/39 (0.00%)  0
Pleural effusion  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Pleuritic pain  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Pneumonitis  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/11 (9.09%)  3 1/7 (14.29%)  6 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Voice alteration  1  0/11 (0.00%)  0 2/7 (28.57%)  6 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Skin and subcutaneous tissue disorders               
Alopecia  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Dry skin  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Erythema multiforme  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Hyperhidrosis  1  0/11 (0.00%)  0 1/7 (14.29%)  3 0/9 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  6 0/6 (0.00%)  0 2/39 (5.13%)  6
Pruritus  1  1/11 (9.09%)  3 0/7 (0.00%)  0 2/9 (22.22%)  6 2/4 (50.00%)  6 0/5 (0.00%)  0 0/6 (0.00%)  0 6/39 (15.38%)  24
Purpura  1  0/11 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  6 0/4 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  3 3/39 (7.69%)  9
Rash maculo-papular  1  2/11 (18.18%)  6 0/7 (0.00%)  0 3/9 (33.33%)  12 2/4 (50.00%)  6 1/5 (20.00%)  3 1/6 (16.67%)  3 5/39 (12.82%)  15
Skin and subcutaneous tissue disorders - Other, specify  1  1/11 (9.09%)  6 1/7 (14.29%)  3 1/9 (11.11%)  3 1/4 (25.00%)  12 1/5 (20.00%)  3 0/6 (0.00%)  0 0/39 (0.00%)  0
Urticaria  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 1/6 (16.67%)  3 2/39 (5.13%)  9
Vascular disorders               
Flushing  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Hot flashes  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Hypertension  1  1/11 (9.09%)  3 0/7 (0.00%)  0 0/9 (0.00%)  0 1/4 (25.00%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 0/39 (0.00%)  0
Phlebitis  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Thromboembolic event  1  0/11 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  3 0/4 (0.00%)  0 1/5 (20.00%)  3 0/6 (0.00%)  0 0/39 (0.00%)  0
Vascular disorders - Other, specify  1  0/11 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/39 (2.56%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Thomas E. Witzig, M.D.
Organization: Mayo Clinic
EMail: witzig.thomas@mayo.edu
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00012298    
Obsolete Identifiers: NCT01646879
Other Study ID Numbers: NCI-2009-00008
NCI-2009-00008 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068503
MC998C ( Other Identifier: Mayo Clinic )
312 ( Other Identifier: CTEP )
First Submitted: March 3, 2001
First Posted: January 27, 2003
Results First Submitted: November 4, 2015
Results First Posted: December 17, 2015
Last Update Posted: August 9, 2018