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MK-0646 and Gemcitabine +/- Erlotinib for Patients With Advanced Pancreatic Cancer

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: NCT00769483
Recruitment Status : Active, not recruiting
First Posted : October 9, 2008
Results First Posted : March 20, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Cancer
Pancreatic Adenocarcinoma
Interventions Drug: MK-0646
Drug: Gemcitabine
Drug: Erlotinib
Enrollment 81
Recruitment Details Completed, last patient enrolled in September 26th, 2013
Pre-assignment Details  
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Hide Arm/Group Description Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Period Title: Overall Study
Started 9 13 15 15 16 9
Completed 9 12 15 15 15 9
Not Completed 0 1 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             1             0
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion Total
Hide Arm/Group Description Arm A: MK-0646 (MK) + gemcitabine(G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. . Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg Total of all reporting groups
Overall Number of Baseline Participants 9 12 15 15 15 9 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 15 participants 15 participants 15 participants 9 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  55.6%
5
  41.7%
9
  60.0%
10
  66.7%
7
  46.7%
6
  66.7%
42
  56.0%
>=65 years
4
  44.4%
7
  58.3%
6
  40.0%
5
  33.3%
8
  53.3%
3
  33.3%
33
  44.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 12 participants 15 participants 15 participants 15 participants 9 participants 75 participants
63.56  (7.21) 63.33  (12.57) 62.33  (7.66) 62.27  (7.62) 67.8  (8.41) 60.89  (9.43) 63.5  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 15 participants 15 participants 15 participants 9 participants 75 participants
Female
3
  33.3%
3
  25.0%
7
  46.7%
6
  40.0%
5
  33.3%
4
  44.4%
28
  37.3%
Male
6
  66.7%
9
  75.0%
8
  53.3%
9
  60.0%
10
  66.7%
5
  55.6%
47
  62.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 15 participants 15 participants 15 participants 9 participants 75 participants
Hispanic or Latino
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
3
  20.0%
0
   0.0%
4
   5.3%
Not Hispanic or Latino
9
 100.0%
11
  91.7%
15
 100.0%
14
  93.3%
12
  80.0%
8
  88.9%
69
  92.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
  11.1%
2
   2.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 15 participants 15 participants 15 participants 9 participants 75 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   8.3%
1
   6.7%
0
   0.0%
2
  13.3%
0
   0.0%
4
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  13.3%
1
   6.7%
0
   0.0%
1
  11.1%
4
   5.3%
White
9
 100.0%
10
  83.3%
12
  80.0%
13
  86.7%
10
  66.7%
7
  77.8%
61
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   8.3%
0
   0.0%
1
   6.7%
3
  20.0%
1
  11.1%
6
   8.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 12 participants 15 participants 15 participants 15 participants 9 participants 75 participants
9 12 15 15 15 9 75
1.Primary Outcome
Title MK-0646 Maximum Tolerable Dose
Hide Description MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib
Time Frame up to 12 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
The primary endpoint is MTD which was analyzed based on phase I participants only. Phase II (Arms A and B) or phase II expansion participants were not included in the analysis per design.
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Hide Arm/Group Description:
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Overall Number of Participants Analyzed 9 12 0 0 0 0
Measure Type: Number
Unit of Measure: participants
MK 5mg +G: #DLT Number Analyzed 3 participants 6 participants 0 participants 0 participants 0 participants 0 participants
0 0
MK 10mg +G: # DLT Number Analyzed 6 participants 6 participants 0 participants 0 participants 0 participants 0 participants
0 2
2.Primary Outcome
Title Progression Free Survival
Hide Description Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
For any group that was not analyzed for Progression Free Survival (PFS) outcome the number of participants has been set to be zero.
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Hide Arm/Group Description:
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E)G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Overall Number of Participants Analyzed 0 0 15 15 15 9
Median (95% Confidence Interval)
Unit of Measure: months
1.8
(1.8 to 9.7)
1.8
(1.7 to 5.5)
1.9
(1.8 to 5.4)
2.0 [1] 
(1.8 to NA)
[1]
Not estimable for the upper bound of the 95% CI
3.Secondary Outcome
Title Overall Survival
Hide Description Time interval (in months) from date of randomization until the date of death from any cause
Time Frame From date of randomization until the date of death from any cause, assessed up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
For any group that was not analyzed for Overall Survival (OS) outcome the number of participants has been set to be zero.
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Hide Arm/Group Description:
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E)G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Overall Number of Participants Analyzed 0 0 15 15 15 9
Median (95% Confidence Interval)
Unit of Measure: months
10.4
(3.9 to 18.9)
7.1
(5.2 to 20.0)
5.7
(4.0 to 9.5)
8.2 [1] 
(5.3 to NA)
[1]
Not estimable for the upper bound of the 95% CI
4.Secondary Outcome
Title Overall Response Rate
Hide Description Complete response + Partial response using RECIST (Response Evaluation Criteria in Solid Tumors)
Time Frame From start of the treatment until disease progression/recurrence; or through study completion (average of 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
For any group that was not analyzed for Overall Response Rate outcome the number of participants has been set to be zero.
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Hide Arm/Group Description:
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E)G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E)G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Overall Number of Participants Analyzed 0 0 15 15 15 9
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
2
  13.3%
1
   6.7%
2
  13.3%
0
   0.0%
5.Secondary Outcome
Title Treatment Toxicity
Hide Description Number of patients who developed toxicity from treatment according to the National Cancer Institute’s Common Terminology Criteria
Time Frame Through the treatment cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Hide Arm/Group Description:
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg
Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily
MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
Overall Number of Participants Analyzed 9 12 15 15 15 9
Measure Type: Count of Participants
Unit of Measure: Participants
9 12 15 15 15 9
6.Other Pre-specified Outcome
Title Correlation Between Tissue IGF-I Expression in Patients Treated With MK-0646 and OS
Hide Description IGF1 expression in tissue was measured and correlated with 1 year patients survival. Inadequate biopsy data for outcome measure.
Time Frame After completing treatment
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Correlation Between Plasma IGF-I Expression in Patients Treated With MK-0646 and OS
Hide Description

IGF1 expression in plasma was measured in patients and correlated with 1 year patients survival.

Inadequate biopsy data for outcome measure.

Time Frame After completing treatment
Outcome Measure Data Not Reported
Time Frame assessed up to 100 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Hide Arm/Group Description Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg
All-Cause Mortality
Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   12/12 (100.00%)   15/15 (100.00%)   15/15 (100.00%)   15/15 (100.00%)   9/9 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   2/12 (16.67%)   2/15 (13.33%)   4/15 (26.67%)   1/15 (6.67%)   1/9 (11.11%) 
Blood and lymphatic system disorders             
G4 thrombocytopenia * 1  0/9 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  1/15 (6.67%)  1/15 (6.67%)  0/9 (0.00%) 
G4 neutropenia for ≥7 days * 1  0/9 (0.00%)  2/12 (16.67%)  2/15 (13.33%)  4/15 (26.67%)  0/15 (0.00%)  1/9 (11.11%) 
1
Term from vocabulary, CTCAE (3.0)
*
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 3.5%
Arm A / Phase I Arm B / Phase I Arm A / Phase II Randomization Arm B / Phase II Randomization Arm C / Phase II Randomization Phase II Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   12/12 (100.00%)   15/15 (100.00%)   15/15 (100.00%)   12/15 (80.00%)   9/9 (100.00%) 
Blood and lymphatic system disorders             
Anemia  1  7/9 (77.78%)  5/12 (41.67%)  7/15 (46.67%)  4/15 (26.67%)  9/15 (60.00%)  1/9 (11.11%) 
Leukopenia  1  9/9 (100.00%)  10/12 (83.33%)  6/15 (40.00%)  4/15 (26.67%)  5/15 (33.33%)  0/9 (0.00%) 
Neutropenia  1  9/9 (100.00%)  8/12 (66.67%)  6/15 (40.00%)  7/15 (46.67%)  9/15 (60.00%)  4/9 (44.44%) 
Thrombocytopenia  1  9/9 (100.00%)  7/12 (58.33%)  9/15 (60.00%)  8/15 (53.33%)  11/15 (73.33%)  7/9 (77.78%) 
Lymphopenia  1  7/9 (77.78%)  3/12 (25.00%)  3/15 (20.00%)  0/15 (0.00%)  3/15 (20.00%)  1/9 (11.11%) 
Cardiac disorders             
Atrial fibrillation  1  0/9 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/9 (0.00%) 
Other cardiac toxicity  1  0/9 (0.00%)  0/12 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/9 (0.00%) 
Endocrine disorders             
Hyperglycemia  1  7/9 (77.78%)  6/12 (50.00%)  8/15 (53.33%)  5/15 (33.33%)  2/15 (13.33%)  2/9 (22.22%) 
Gastrointestinal disorders             
Anorexia  1  3/9 (33.33%)  6/12 (50.00%)  2/15 (13.33%)  4/15 (26.67%)  5/15 (33.33%)  1/9 (11.11%) 
Nausea  1  4/9 (44.44%)  7/12 (58.33%)  2/15 (13.33%)  3/15 (20.00%)  7/15 (46.67%)  4/9 (44.44%) 
GIT hemorrhage  1  1/9 (11.11%)  0/12 (0.00%)  2/15 (13.33%)  0/15 (0.00%)  0/15 (0.00%)  0/9 (0.00%) 
Diarrhea  1  4/9 (44.44%)  6/12 (50.00%)  1/15 (6.67%)  7/15 (46.67%)  5/15 (33.33%)  1/9 (11.11%) 
General disorders             
Fatigue  1  6/9 (66.67%)  10/12 (83.33%)  6/15 (40.00%)  4/15 (26.67%)  7/15 (46.67%)  8/9 (88.89%) 
Hepatobiliary disorders             
Elevated ALK  1  3/9 (33.33%)  3/12 (25.00%)  5/15 (33.33%)  1/15 (6.67%)  2/15 (13.33%)  0/9 (0.00%) 
Elevated ALT  1  4/9 (44.44%)  6/12 (50.00%)  5/15 (33.33%)  3/15 (20.00%)  2/15 (13.33%)  3/9 (33.33%) 
Elevated AST  1  5/9 (55.56%)  5/12 (41.67%)  6/15 (40.00%)  6/15 (40.00%)  3/15 (20.00%)  2/9 (22.22%) 
Infections and infestations             
Infection  1  1/9 (11.11%)  1/12 (8.33%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/9 (0.00%) 
Investigations             
Elevated INR  1  0/9 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/9 (0.00%) 
Hyperkalemia  1  1/9 (11.11%)  0/12 (0.00%)  1/15 (6.67%)  1/15 (6.67%)  1/15 (6.67%)  0/9 (0.00%) 
Hyponatremia  1  2/9 (22.22%)  3/12 (25.00%)  2/15 (13.33%)  2/15 (13.33%)  0/15 (0.00%)  0/9 (0.00%) 
Vascular disorders             
Thrombosis  1  0/9 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  2/15 (13.33%)  0/15 (0.00%)  0/9 (0.00%) 
Pulmonary embolism  1  0/9 (0.00%)  0/12 (0.00%)  0/15 (0.00%)  2/15 (13.33%)  0/15 (0.00%)  0/9 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by 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: Milind Javle, MD/Professor, GI Medical Oncology
Organization: UT MD Anderson Cancer Center
Phone: 713-792-2828
EMail: mjavle@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00769483     History of Changes
Other Study ID Numbers: 2007-0910
NCI-2010-01049 ( Registry Identifier: NCI CTRP )
First Submitted: October 8, 2008
First Posted: October 9, 2008
Results First Submitted: May 9, 2018
Results First Posted: March 20, 2019
Last Update Posted: April 30, 2019