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Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02186834
Recruitment Status : Active, not recruiting
First Posted : July 10, 2014
Results First Posted : February 19, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Karyopharm Therapeutics Inc
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Selinexor
Drug: Liposomal doxorubicin
Drug: Dexamethasone
Enrollment 28
Recruitment Details Participants were recruited at Moffitt Cancer Center and Karmanos Cancer Center September 2014 through May 2017.
Pre-assignment Details 6 of the 14 participants treated at RP2D moved on from Dose 2m arm in the dose escalation portion of study.
Arm/Group Title Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D
Hide Arm/Group Description Dose 1: Participants were administered Lipodox 20 mg/m^2 via IV on Day 1 of cycle. Selinexor at 40 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Dose 2: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Dose 1m: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 60 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Dose 2m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Dose 3m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,3, 8 and 10 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Phase 2 Dose: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
Period Title: Dose Escalation
Started 6 3 0 7 4 0
Completed 6 3 0 6 4 0
Not Completed 0 0 0 1 0 0
Reason Not Completed
Death             0             0             0             1             0             0
Period Title: Treatment at RP2D
Started 0 0 0 0 0 14
Completed 0 0 0 0 0 13
Not Completed 0 0 0 0 0 1
Reason Not Completed
Died prior to treatment             0             0             0             0             0             1
Arm/Group Title Selinexor, Liposomal Doxorubicin and Dexamethasone
Hide Arm/Group Description Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
All participants who received treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
60
(49 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
14
  51.9%
Male
13
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Hispanic or Latino
3
  11.1%
Not Hispanic or Latino
24
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  11.1%
White
21
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
2
   7.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D): Selinexor on Days 1, 8 and 15 when given in combination with Lipodox 20 mg/m^2 and Dexamethasone 40 mg.

Dose level 1: 40 mg in combination with Lipodox and Dexamethasone.

Dose level 2: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone.

Dose level 2m: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone.

Dose level 3m: 80 mg (D1,3,8,10) in combination with Lipodox and Dexamethasone.

Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated during dose escalation
Arm/Group Title Selinexor, Liposomal Doxorubicin and Dexamethasone
Hide Arm/Group Description:
Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: mg
80
2.Primary Outcome
Title Overall Response Rate (ORR) - All Participants
Hide Description ORR per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): >/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >/= 90% or to < 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow. Stable Disease: Not meeting criteria for CR, VGPR, PR, or progressive disease. Minimal response: Less than 50% decrease in M protein. Not evaluable: Cannot be measured because enough information has not been collected.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Selinexor, Liposomal Doxorubicin and Dexamethasone
Hide Arm/Group Description:
Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
>/= Very Good Partial Response
2
   7.4%
>/= Partial Response
4
  14.8%
>/= Minimal Response
9
  33.3%
Stable Disease
8
  29.6%
Not Evaluable
4
  14.8%
3.Primary Outcome
Title Overall Response Rate (ORR) -All Participants Treated at Recommended Phase 2 Dose
Hide Description Determine the overall response rate per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): >/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >/= 90% or to < 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated at recommended phase 2 dose, regardless of when they joined the study.
Arm/Group Title Selinexor, Liposomal Doxorubicin and Dexamethasone
Hide Arm/Group Description:
Combination Therapy: Phase I Dose Escalation followed by Phase 2 treatment at Recommended Phase 2 Dose (RP2D)
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
>/= Very Good Partial Response
0
   0.0%
>/= Partial Response
1
   7.1%
>/= Minimal Response
2
  14.3%
Stable Disease
4
  28.6%
Not Evaluable
1
   7.1%
Time Frame 3 years, 2 months
Adverse Event Reporting Description All Adverse Events (AEs) and Serious Adverse Events (SAEs) at all grade levels, regardless of causality have been reported in this section. One participant died prior to treatment but after consent. Only participants who received treatment were considered at Risk for Serious and Other Adverse Events.
 
Arm/Group Title Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D
Hide Arm/Group Description Dose 1: Participants were administered Lipodox 20 mg/m^2 via IV on Day 1 of cycle. Selinexor at 40 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Dose 2: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle.

Dexamethasone at 40 mg was given orally on days 1, 8 and 15.

Dose 1m: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 60 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Dose 2m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Dose 3m: Participants were administered Lipodox 20mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,3, 8 and 10 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15. Phase 2 Dose: Participants were administered Lipodox 20 mg/m^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
All-Cause Mortality
Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)      1/3 (33.33%)      0/0      1/7 (14.29%)      0/4 (0.00%)      1/8 (12.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D
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   4/6 (66.67%)      1/1 (100.00%)      0/0      6/7 (85.71%)      0/4 (0.00%)      0/7 (0.00%)    
Blood and lymphatic system disorders             
Anemia * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Blood and lymphatic system disorders - Other * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Cardiac disorders             
Atrial fibrillation * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders             
Constipation * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Dental caries * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Diarrhea * 1  2/6 (33.33%)  2 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Fecal incontinence * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Mucositis oral * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Nausea * 1  2/6 (33.33%)  2 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Vomiting * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
General disorders             
Chills * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Death * 1  1/6 (16.67%)  1 1/1 (100.00%)  1 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Edema face * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Edema limbs * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Fever * 1  2/6 (33.33%)  3 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations             
Pneumocystitis pneumonia * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Streptococcal pneumonia * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
RSV pneumonia * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Pleural infection * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Sepsis * 1  2/6 (33.33%)  2 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Upper respiratory infection * 1  2/6 (33.33%)  2 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Urinary tract infection * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Investigations             
CPK increased * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Platelet count decreased * 1  3/6 (50.00%)  3 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Muscle weakness lower limb * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal deformity * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Pain in extremity * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders             
Dizziness * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Lethargy * 1  0/6 (0.00%)  0 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Renal and urinary disorders             
Acute kidney injury * 1  1/6 (16.67%)  1 0/1 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2 Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D
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   5/6 (83.33%)      3/3 (100.00%)      0/0      7/7 (100.00%)      4/4 (100.00%)      6/7 (85.71%)    
Blood and lymphatic system disorders             
Anemia * 1  2/6 (33.33%)  7 3/3 (100.00%)  8 0/0  0 3/7 (42.86%)  3 2/4 (50.00%)  3 2/7 (28.57%)  2
Febrile neutropenia * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Thrombotic thrombocytopenia purpura * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Cardiac disorders             
Ventricular tachycardia * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Ear and labyrinth disorders             
Ear and labyrinth disorders - Other * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Eye disorders             
Blurred vision * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1
Cataract * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Watering eyes * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders             
Nausea * 1  4/6 (66.67%)  6 2/3 (66.67%)  2 0/0  0 1/7 (14.29%)  1 3/4 (75.00%)  3 1/7 (14.29%)  2
Diarrhea * 1  2/6 (33.33%)  6 1/3 (33.33%)  1 0/0  0 2/7 (28.57%)  2 0/4 (0.00%)  0 0/7 (0.00%)  0
Vomiting * 1  2/6 (33.33%)  6 1/3 (33.33%)  2 0/0  0 2/7 (28.57%)  4 1/4 (25.00%)  1 1/7 (14.29%)  2
Mucositis oral * 1  1/6 (16.67%)  1 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Constipation * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 2/7 (28.57%)  2 0/4 (0.00%)  0 0/7 (0.00%)  0
Dry Mouth * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Fecal incontinence * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Gastroesophageal reflux disease * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
General disorders             
Fatigue * 1  2/6 (33.33%)  4 2/3 (66.67%)  2 0/0  0 2/7 (28.57%)  2 2/4 (50.00%)  2 3/7 (42.86%)  3
Fever * 1  1/6 (16.67%)  3 1/3 (33.33%)  1 0/0  0 4/7 (57.14%)  5 0/4 (0.00%)  0 0/7 (0.00%)  0
Edema limbs * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 2/7 (28.57%)  2 1/4 (25.00%)  1 0/7 (0.00%)  0
Flu like symptoms * 1  2/6 (33.33%)  2 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Chills * 1  0/6 (0.00%)  0 1/3 (33.33%)  3 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
General disorders - Other * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Localized edema * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Pain * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Infections and infestations             
Infections and infestations - Other * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Sinusitis * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Upper Respiratory Infection * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 1/7 (14.29%)  1
Urinary tract infection * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Bronchial infection * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Lung infection * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Pleural infection * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Skin Infection * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Tooth infection * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Injury, poisoning and procedural complications             
Fall * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Investigations             
Platelet count decreased * 1  4/6 (66.67%)  10 3/3 (100.00%)  12 0/0  0 3/7 (42.86%)  5 1/4 (25.00%)  1 1/7 (14.29%)  3
White blood cell decreased * 1  5/6 (83.33%)  10 3/3 (100.00%)  9 0/0  0 3/7 (42.86%)  4 1/4 (25.00%)  3 0/7 (0.00%)  0
Neurtrophil count decreased * 1  4/6 (66.67%)  9 3/3 (100.00%)  5 0/0  0 2/7 (28.57%)  4 1/4 (25.00%)  1 1/7 (14.29%)  1
Lymphocyte count decreased * 1  3/6 (50.00%)  5 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Alanine aminotransferase increased * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/4 (25.00%)  1 1/7 (14.29%)  1
Aspartate aminotransferase increased * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 1/7 (14.29%)  1
Weight loss * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 2/7 (28.57%)  2 0/4 (0.00%)  0 0/7 (0.00%)  0
Alkaline phosphatase increased * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Blood bilirubin increased * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
CPK increased * 1  1/6 (16.67%)  2 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Creatinine increased * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders             
Hyponatremia * 1  3/6 (50.00%)  5 2/3 (66.67%)  3 0/0  0 2/7 (28.57%)  5 0/4 (0.00%)  0 1/7 (14.29%)  1
Anorexia * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 3/7 (42.86%)  3 1/4 (25.00%)  1 1/7 (14.29%)  1
Hyperglycemia * 1  1/6 (16.67%)  3 1/3 (33.33%)  1 0/0  0 2/7 (28.57%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1
Dehydration * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 1/7 (14.29%)  2 1/4 (25.00%)  1 1/7 (14.29%)  1
Hypocalcemia * 1  2/6 (33.33%)  2 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Hypoalbuminemia * 1  1/6 (16.67%)  1 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Hypophosphatemia * 1  1/6 (16.67%)  2 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Pain in extremity * 1  2/6 (33.33%)  2 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Arthralgia * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Back Pain * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
General muscle weakness * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders -Other * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Osteonecrosis of jaw * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders             
Dysgeusia * 1  0/6 (0.00%)  0 2/3 (66.67%)  2 0/0  0 2/7 (28.57%)  2 2/4 (50.00%)  2 0/7 (0.00%)  0
Amnesia * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Headache * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Lethargy * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Psychiatric disorders             
Depression * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Psychiatric disorders - Other * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Renal and urinary disorders             
Renal and urinary disorders - Other * 1  1/6 (16.67%)  1 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Renal calculi * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Urinary frequency * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Urinary incontinence * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders             
Reproductive system and breast disorders - Other * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders             
Cough * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Adult respiratory distress syndrom * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Epistaxis * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Hiccups * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Productive cough * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Respiratory failure * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders -Other * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders             
Erythroderma * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Palmer-plantar erythrodesthesia syndrome * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Surgical and medical procedures             
Surgical and medical procedures - Other * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Vascular disorders             
Thromboembolic event * 1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Hot flashes * 1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Hypertension * 1  1/6 (16.67%)  3 0/3 (0.00%)  0 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Hypotension * 1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/7 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rachid Baz
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-8212
EMail: rachid.baz@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02186834     History of Changes
Other Study ID Numbers: MCC-17814
First Submitted: July 8, 2014
First Posted: July 10, 2014
Results First Submitted: August 30, 2018
Results First Posted: February 19, 2019
Last Update Posted: August 28, 2019