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BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

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: NCT02257541
Recruitment Status : Completed
First Posted : October 6, 2014
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
M.D. Anderson Cancer Center
University of Pittsburgh
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Gastrointestinal Stromal Tumor (GIST)
Interventions Drug: BGJ398
Drug: Imatinib Mesylate
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2 Phase 1b, Dose Level -2 Phase II
Hide Arm/Group Description Phase 1b, Dose Level -1: BGJ398 50 mg Phase 1b, Dose Level 1: BGJ398 75 mg Phase 1b, Dose Level 2: BGJ398 100 mg Phase 1b, Dose Level -2: BGJ398 25 mg Phase II: BGJ398 75mg
Period Title: Overall Study
Started 3 8 1 3 1
Completed 3 8 1 3 1
Not Completed 0 0 0 0 0
Arm/Group Title Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2 Phase 1b, Dose Level -2 Phase II Total
Hide Arm/Group Description Phase 1b, Dose Level -1: BGJ398 50 mg Phase 1b, Dose Level 1: BGJ398 75 mg Phase 1b, Dose Level 2: BGJ398 100 mg Phase 1b, Dose Level -2: BGJ398 25 mg Phase II: BGJ398 75mg Total of all reporting groups
Overall Number of Baseline Participants 3 8 1 3 1 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 8 participants 1 participants 3 participants 1 participants 16 participants
54
(48 to 65)
58.88
(47 to 77)
44
(44 to 44)
53
(49 to 64)
53
(53 to 53)
54
(44 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 8 participants 1 participants 3 participants 1 participants 16 participants
Female
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
1
 100.0%
3
  18.8%
Male
3
 100.0%
6
  75.0%
1
 100.0%
3
 100.0%
0
   0.0%
13
  81.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 8 participants 1 participants 3 participants 1 participants 16 participants
Hispanic or Latino
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
Not Hispanic or Latino
3
 100.0%
6
  75.0%
0
   0.0%
3
 100.0%
0
   0.0%
12
  75.0%
Unknown or Not Reported
0
   0.0%
1
  12.5%
1
 100.0%
0
   0.0%
1
 100.0%
3
  18.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 8 participants 1 participants 3 participants 1 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  33.3%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
2
  12.5%
White
2
  66.7%
4
  50.0%
1
 100.0%
3
 100.0%
0
   0.0%
10
  62.5%
More than one race
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
  12.5%
0
   0.0%
0
   0.0%
1
 100.0%
2
  12.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 8 participants 1 participants 3 participants 1 participants 16 participants
3
 100.0%
8
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
16
 100.0%
1.Primary Outcome
Title Phase Ib Study: Number of Participants With Dose-Limiting Toxicities
Hide Description The phase Ib will be pursued in standard 3+3 format, based on toxicities encountered during the first cycle of therapy.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2 Phase 1b, Dose Level -2
Hide Arm/Group Description:
Phase 1b, Dose Level -1: BGJ398 50 mg
Phase 1b, Dose Level 1: BGJ398 75 mg
Phase 1b, Dose Level 2: BGJ398 100 mg
Phase 1b, Dose Level -2: BGJ398 25 mg
Overall Number of Participants Analyzed 3 8 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
8
 100.0%
1
 100.0%
3
 100.0%
2.Primary Outcome
Title Phase Ib Portion: Response Rate (RR)
Hide Description

(CR+PR, RECIST 1.1) and by CHOI criteria

PHASE 1b PARTICIPANTS ONLY

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2 Phase 1b, Dose Level -2
Hide Arm/Group Description:
Phase 1b, Dose Level -1: BGJ398 50 mg
Phase 1b, Dose Level 1: BGJ398 75 mg
Phase 1b, Dose Level 2: BGJ398 100 mg
Phase 1b, Dose Level -2: BGJ398 25 mg
Overall Number of Participants Analyzed 3 8 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response/PR
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
Stable Disease/SD
2
  66.7%
3
  37.5%
0
   0.0%
0
   0.0%
Progressive Disease/PD
0
   0.0%
3
  37.5%
1
 100.0%
3
 100.0%
Not reported due to withdrawn from study
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Phase Ib Study: Response Rate (RR)
Hide Description

defined by RECIST 1.1 criteria and by CHOI criteria,and by EORTC criteria

PHASE 1b PARTICIPANTS ONLY

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2 Phase 1b, Dose Level -2
Hide Arm/Group Description:
Phase 1b, Dose Level -1: BGJ398 50 mg
Phase 1b, Dose Level 1: BGJ398 75 mg
Phase 1b, Dose Level 2: BGJ398 100 mg
Phase 1b, Dose Level -2: BGJ398 25 mg
Overall Number of Participants Analyzed 3 8 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
Progressive Disease/PD
1
  33.3%
2
  25.0%
0
   0.0%
3
 100.0%
Stable Disease/SD
2
  66.7%
4
  50.0%
1
 100.0%
0
   0.0%
Not reported due to withdrawn from study
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2: Phase 1b, Dose Level -2 Phase II
Hide Arm/Group Description Phase 1b, Dose Level -1: BGJ398 50 mg Phase 1b, Dose Level 1: BGJ398 75 mg Phase 1b, Dose Level 2: BGJ398 100 mg Phase 1b, Dose Level -2: BGJ398 25 mg Phase II: BGJ398 75mg
All-Cause Mortality
Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2: Phase 1b, Dose Level -2 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   3/8 (37.50%)   0/1 (0.00%)   0/3 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2: Phase 1b, Dose Level -2 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   7/8 (87.50%)   1/1 (100.00%)   3/3 (100.00%)   0/1 (0.00%) 
Cardiac disorders           
Myocardial Infarction   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Intra-Abdominal Bleeding   0/3 (0.00%)  0/8 (0.00%)  1/1 (100.00%)  0/3 (0.00%)  0/1 (0.00%) 
General disorders           
Fatigue   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Investigations           
CPK increased   1/3 (33.33%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Ejection Fraction decreased   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Lipase Increased   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back Pain   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnea   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Pleural Effusion   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Vascular disorders           
Hypertension   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 1b, Dose Level -1 Phase 1b, Dose Level 1 Phase 1b, Dose Level 2: Phase 1b, Dose Level -2 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   8/8 (100.00%)   1/1 (100.00%)   3/3 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders           
Anemia   3/3 (100.00%)  3/8 (37.50%)  1/1 (100.00%)  0/3 (0.00%)  1/1 (100.00%) 
Cardiac disorders           
Chest Pain - Cardiac   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Myocardial infarction   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Sinus bradycardia   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Endocrine disorders           
Hypothyroidism   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Eye disorders           
Flashing Lights   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Blurred Vision   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Dry Eye   0/3 (0.00%)  2/8 (25.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Periorbital edema   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/3 (33.33%)  1/1 (100.00%) 
Watering eyes   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  1/1 (100.00%) 
Gastrointestinal disorders           
Abdominal pain   3/3 (100.00%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  1/1 (100.00%) 
Constipation   1/3 (33.33%)  3/8 (37.50%)  1/1 (100.00%)  0/3 (0.00%)  0/1 (0.00%) 
Diarrhea   1/3 (33.33%)  3/8 (37.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Dry Mouth   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Dyspepsia   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Vomiting   1/3 (33.33%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Anorexia   0/3 (0.00%)  2/8 (25.00%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Ascites   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Bloating   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Nausea   0/3 (0.00%)  2/8 (25.00%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Gastritis   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
General disorders           
Edema Limbs   1/3 (33.33%)  1/8 (12.50%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Fatigue   2/3 (66.67%)  5/8 (62.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Pain   1/3 (33.33%)  0/8 (0.00%)  1/1 (100.00%)  0/3 (0.00%)  0/1 (0.00%) 
Fever   0/3 (0.00%)  0/8 (0.00%)  1/1 (100.00%)  0/3 (0.00%)  0/1 (0.00%) 
Non-cardiac chest pain   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  1/1 (100.00%) 
Investigations           
AST Elevated   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  2/3 (66.67%)  0/1 (0.00%) 
CPK Increased   3/3 (100.00%)  4/8 (50.00%)  0/1 (0.00%)  1/3 (33.33%)  1/1 (100.00%) 
Creatinine Increased   1/3 (33.33%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Decreased TSH   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Electrocardiogram QT corrected interval prolonged   1/3 (33.33%)  0/8 (0.00%)  1/1 (100.00%)  1/3 (33.33%)  1/1 (100.00%) 
Lipase Increased   2/3 (66.67%)  3/8 (37.50%)  0/1 (0.00%)  1/3 (33.33%)  1/1 (100.00%) 
Alanine aminotransferase increased   1/3 (33.33%)  0/8 (0.00%)  1/1 (100.00%)  0/3 (0.00%)  0/1 (0.00%) 
Alkaline phosphatase increased   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Blood bilirubin increased   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Serum amylase increased   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Weight gain   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Weight loss   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Ejection fraction decreased   0/3 (0.00%)  0/8 (0.00%)  1/1 (100.00%)  1/3 (33.33%)  0/1 (0.00%) 
Metabolism and nutrition disorders           
Hyperglycemia   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Hyperkalemia   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Hyperphosphatemia   2/3 (66.67%)  1/8 (12.50%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Hypoalbuminemia   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  1/1 (100.00%) 
Hypocalcemia   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders           
Back Pain   1/3 (33.33%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Myalgia   1/3 (33.33%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Muscle weakness lower limb   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Nervous system disorders           
Dysgeusia   0/3 (0.00%)  2/8 (25.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Memory Impairment   0/3 (0.00%)  2/8 (25.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Headache   0/3 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Psychiatric disorders           
Anxiety   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Sleep Apnea   1/3 (33.33%)  0/8 (0.00%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Cough   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Dyspnea   0/3 (0.00%)  3/8 (37.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Epistaxis   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Pleural effusion   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders           
Dry Skin   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Skin hyperpigmentation   0/3 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Vascular disorders           
Hypertension   1/3 (33.33%)  2/8 (25.00%)  1/1 (100.00%)  1/3 (33.33%)  1/1 (100.00%) 
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: Dr. William Tap, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4163
EMail: tapw@mskcc.org
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02257541    
Other Study ID Numbers: 14-140
First Submitted: October 2, 2014
First Posted: October 6, 2014
Results First Submitted: February 13, 2020
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020