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Pazopanib in Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST)

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ClinicalTrials.gov Identifier: NCT01391611
Recruitment Status : Terminated (Lack of efficacy - Futility endpoint reached)
First Posted : July 12, 2011
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastrointestinal Stromal Tumor (GIST)
Intervention Drug: Pazopanib
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pazopanib Arm
Hide Arm/Group Description Pazopanib: 800 mg; PO
Period Title: Overall Study
Started 25
Completed 3
Not Completed 22
Arm/Group Title Pazopanib Arm
Hide Arm/Group Description Pazopanib: 800 mg; PO
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
59
(27 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
10
  40.0%
Male
15
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
1
   4.0%
Not Hispanic or Latino
22
  88.0%
Unknown or Not Reported
2
   8.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  12.0%
White
18
  72.0%
More than one race
0
   0.0%
Unknown or Not Reported
3
  12.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)
Hide Description

4-mo non-progression rate

"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; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pazopanib Arm
Hide Arm/Group Description:
Pazopanib: 800 mg; PO
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.6 to 5.2)
2.Secondary Outcome
Title Response Per Choi Criteria
Hide Description

Response per Choi criteria

  • Complete response - Disappearance of all lesions; no new lesion
  • Partial response - A decrease in size of > or = 10% or a decrease in tumor density (HU) > or = 15% on CT. No new lesions. No obvious progression of nonmeasurable disease.
  • Stable disease - Does not meet the criteria for CR, PR, or PD. No symptomatic deterioration attributed to tumor progression.
  • Progressive disease - An increase in tumor size of > or = 10% and does not meet criteria of PR by tumor density (HU) on CT. New lesions. New intratumoral nodules or increase in the size of the existing intratumoral nodules.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Choi criteria measurements were not done due to technical difficulties.
Arm/Group Title Pazopanib Arm
Hide Arm/Group Description:
Pazopanib: 800 mg; PO
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported. These were captured every months at clinic visit and patients also could report in between visits.
Adverse Event Reporting Description Patients were asked about adverse events at every clinic visit.
 
Arm/Group Title Pazopanib Arm
Hide Arm/Group Description Pazopanib: 800 mg; PO
All-Cause Mortality
Pazopanib Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pazopanib Arm
Affected / at Risk (%) # Events
Total   14/25 (56.00%)    
Blood and lymphatic system disorders   
Anemia G2 † 1  1/25 (4.00%)  1
Gastrointestinal disorders   
Worsened ascites G1 † 1  1/25 (4.00%)  1
Constipation G2 † 1  1/25 (4.00%)  1
GI disorders-other, E. coli bacteremia G3 † 1  1/25 (4.00%)  1
Intestinal perforation G4 † 1  1/25 (4.00%)  1
Ascites G3 † 1  2/25 (8.00%)  2
Abdominal pain G3 † 1  2/25 (8.00%)  4
GI Bleed G3 † 1  2/25 (8.00%)  2
Rectal hemorrhage, rectum bleeding † 1  1/25 (4.00%)  1
GI Bleed G5 † 1  1/25 (4.00%)  1
Acute pancreatitis G3 † 1  1/25 (4.00%)  1
General disorders   
General disorders and administration site conditions-other, specify, Disease progression-fatal G5 † 1  1/25 (4.00%)  1
Fatigue G2 † 1  1/25 (4.00%)  1
Worsening fatigue G3 † 1  1/25 (4.00%)  1
Hepatobiliary disorders   
Nonviral hepatitis/transaminitis G2 † 1  1/25 (4.00%)  1
Investigations   
Blood bilirubin increased G3 † 1  1/25 (4.00%)  1
Alkaline phosphatase increased G3 † 1  1/25 (4.00%)  1
AST incresed G3 † 1  1/25 (4.00%)  1
ALT increased G3 † 1  1/25 (4.00%)  1
GGT increased G3 † 1  1/25 (4.00%)  1
Metabolism and nutrition disorders   
Hypoalbuminemia G3 † 1  1/25 (4.00%)  1
Dehydration G3 † 1  1/25 (4.00%)  1
Nervous system disorders   
Peripheral motor neuropathy G2 † 1  1/25 (4.00%)  1
Seizure G3 † 1  1/25 (4.00%)  1
Cognitive disturbance G2 † 1  1/25 (4.00%)  1
Renal and urinary disorders   
Renal failure G5 † 1  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Worsened shortness of breath † 1  1/25 (4.00%)  1
Pulmonary embolism G3 † 1  1/25 (4.00%)  1
Pneumonia G1 † 1  1/25 (4.00%)  1
Worsened right pleural effusion G1 † 1  1/25 (4.00%)  1
Skin and subcutaneous tissue disorders   
Sacral decubitus G1 † 1  1/25 (4.00%)  1
Vascular disorders   
Deep venous thrombosis G1 † 1  1/25 (4.00%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pazopanib Arm
Affected / at Risk (%) # Events
Total   25/25 (100.00%)    
Blood and lymphatic system disorders   
Worsened anemia G1 † 1  2/25 (8.00%)  2
Worsened anemia G2 † 1  1/25 (4.00%)  1
Worsening anemia G3 † 1  1/25 (4.00%)  1
Anemia (secondary to GI bleed) G3 † 1  1/25 (4.00%)  1
Neutropenia G2 † 1  2/25 (8.00%)  3
Leukopenia G2 † 1  1/25 (4.00%)  1
Leukopenia G1 † 1  1/25 (4.00%)  1
Thrombocytopenia G1 † 1  1/25 (4.00%)  1
Endocrine disorders   
Hypothyroidism G2 † 1  1/25 (4.00%)  1
Gastrointestinal disorders   
Vomiting G1 † 1  6/25 (24.00%)  6
Intermittent vomiting G1 † 1  4/25 (16.00%)  4
Vomiting G2 † 1  1/25 (4.00%)  1
Vomiting G3 † 1  1/25 (4.00%)  1
Intermittent nausea G1 † 1  3/25 (12.00%)  3
Nausea G1 † 1  6/25 (24.00%)  7
Nausea G2 † 1  1/25 (4.00%)  1
Nausea G3 † 1  1/25 (4.00%)  1
Intermittent worsened abdominal pain w/ radiation to R shoulder G2 † 1  1/25 (4.00%)  1
Intermittent diarrhea G1 † 1  2/25 (8.00%)  2
Diarrhea G1 † 1  9/25 (36.00%)  9
Intermittent constipation G1 † 1  2/25 (8.00%)  2
Constipation G2 † 1  1/25 (4.00%)  1
Intermittent cramps abdomen G1 † 1  1/25 (4.00%)  1
Early satiety G1 † 1  3/25 (12.00%)  3
Hemorrhoids G1 † 1  1/25 (4.00%)  1
Constipation G1 † 1  2/25 (8.00%)  2
Abdominal cramping G2 † 1  1/25 (4.00%)  1
Intermittent postprandial cramping G1 † 1  1/25 (4.00%)  1
Intermittent abdominal pain G1 † 1  1/25 (4.00%)  1
Abdominal pain G1 † 1  4/25 (16.00%)  4
Left lower abdominal and lower back pain † 1  1/25 (4.00%)  1
Abdominal pain G2 † 1  5/25 (20.00%)  6
Worsened LUQ pain G3 † 1  1/25 (4.00%)  1
Axorexia G2 † 1  1/25 (4.00%)  1
Intermittent sore mouth G1 † 1  1/25 (4.00%)  1
Mouth pain G1 † 1  3/25 (12.00%)  3
Oral dysesthesia G1 † 1  1/25 (4.00%)  1
Dysgeusia G1 † 1  1/25 (4.00%)  1
Ascites G3 † 1  1/25 (4.00%)  1
Retching G1 † 1  1/25 (4.00%)  1
Bloating G1 † 1  1/25 (4.00%)  1
General disorders   
Fatigue G1 † 1  5/25 (20.00%)  7
Fatigue G2 † 1  8/25 (32.00%)  8
Intermittent night sweats G1 † 1  2/25 (8.00%)  2
Weight loss G1 † 1  2/25 (8.00%)  2
Fever G1 † 1  1/25 (4.00%)  1
Pain G2 † 1  2/25 (8.00%)  2
Drowsiness G1 † 1  1/25 (4.00%)  1
Dehydration G3 † 1  1/25 (4.00%)  1
Lightheadedness G1 † 1  1/25 (4.00%)  1
Dizziness G1 † 1  1/25 (4.00%)  1
Infections and infestations   
Thrush (mucosal infection) G1 † 1  1/25 (4.00%)  1
oral candidiasis G2 † 1  1/25 (4.00%)  1
Investigations   
Blood bilirubin increased G1 † 1  2/25 (8.00%)  2
Blood bilirubin increased G2 † 1  1/25 (4.00%)  1
Alkaline phosphatase increased G1 † 1  1/25 (4.00%)  1
GGT increased G1 † 1  1/25 (4.00%)  1
ALT increased G1 † 1  1/25 (4.00%)  1
AST increased G1 † 1  2/25 (8.00%)  2
AST increased G2 † 1  1/25 (4.00%)  1
Alkaline phosphatase increased G2 † 1  1/25 (4.00%)  1
GGT increased G2 † 1  1/25 (4.00%)  1
Metabolism and nutrition disorders   
Hyperkalemia G2 † 1  1/25 (4.00%)  1
Decreased appetite G1 † 1  2/25 (8.00%)  2
Decreased appetite G2 † 1  1/25 (4.00%)  1
Anorexia G1 † 1  2/25 (8.00%)  2
Hypomagnesemia G1 † 1  3/25 (12.00%)  3
Hypoalbuminemia G2 † 1  1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders   
Worsened back pain G1 † 1  1/25 (4.00%)  1
Jaw pain right G1 † 1  1/25 (4.00%)  1
Bilateral femur pain † 1  1/25 (4.00%)  1
Intermittent back pain G1 † 1  2/25 (8.00%)  2
Worsened low back pain with radiation to buttocks, R hip G2 † 1  1/25 (4.00%)  1
Acute lower back pain G2 † 1  1/25 (4.00%)  1
Intermittent cramps, feet † 1  1/25 (4.00%)  1
Intermittent pain/cramps legs G1 † 1  1/25 (4.00%)  1
Pain elbow G1 † 1  1/25 (4.00%)  1
Decreased strength G1 † 1  1/25 (4.00%)  1
Weakness lower extremities G2 † 1  1/25 (4.00%)  1
Generalized weakness G1 † 1  1/25 (4.00%)  1
Pain B/L legs R>L G1 † 1  1/25 (4.00%)  1
Joint and muscle pain G1 † 1  1/25 (4.00%)  1
Intermittent right shoulder pain G1 † 1  1/25 (4.00%)  1
Worsening pain G1 † 1  1/25 (4.00%)  1
Left wrist pain with cellulitis † 1  1/25 (4.00%)  1
Lower back and left calf pain G2 † 1  1/25 (4.00%)  1
Intermittent leg cramps G1 † 1  2/25 (8.00%)  2
Leg cramps (pain) G2 † 1  1/25 (4.00%)  1
Muscle weakness G1 † 1  1/25 (4.00%)  1
Left ankle weakness G2 † 1  1/25 (4.00%)  1
Nervous system disorders   
Loss of consciousness, transient G1 † 1  1/25 (4.00%)  1
Headache G1 † 1  6/25 (24.00%)  6
Headache G3 † 1  1/25 (4.00%)  1
Psychiatric disorders   
Anxiety G1 † 1  1/25 (4.00%)  1
Insomnia G1 † 1  1/25 (4.00%)  1
Renal and urinary disorders   
Urinary tract infection G1 † 1  1/25 (4.00%)  1
Decreased urine output † 1  1/25 (4.00%)  1
Cystitis G1 † 1  1/25 (4.00%)  1
Proteinuria G2 † 1  1/25 (4.00%)  1
Proteinuria G3 † 1  1/25 (4.00%)  1
Elevated UPC G1 † 1  1/25 (4.00%)  1
Reproductive system and breast disorders   
Vaginal bleeding G1 † 1  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Shortness of breath G1 † 1  2/25 (8.00%)  2
Worsened DOE G1 † 1  1/25 (4.00%)  2
Dyspnea G1 † 1  2/25 (8.00%)  2
Upper respiratory symptoms G1 † 1  1/25 (4.00%)  1
Epistaxis G1 † 1  3/25 (12.00%)  3
Rhinorrhea and throat discomfort † 1  1/25 (4.00%)  1
Cough G1 † 1  1/25 (4.00%)  1
Epistaxis G2 † 1  1/25 (4.00%)  1
Skin and subcutaneous tissue disorders   
Facial flushing G1 † 1  1/25 (4.00%)  1
Generalized depigmentation G2 † 1  1/25 (4.00%)  1
Hand/foot syndrome † 1  3/25 (12.00%)  3
Rash G1 † 1  3/25 (12.00%)  3
Facial and hand edema G1 † 1  1/25 (4.00%)  1
Infection - rash G2 † 1  1/25 (4.00%)  1
Skin irritation - perianal G1 † 1  1/25 (4.00%)  1
Hypopigmentation B/L forearms G1 † 1  1/25 (4.00%)  1
Skin dryness G1 † 1  2/25 (8.00%)  2
Whitening of hair G1 † 1  1/25 (4.00%)  1
Pruritus G1 † 1  1/25 (4.00%)  1
Hair lightening G2 † 1  1/25 (4.00%)  1
Vascular disorders   
Hypertension G1 † 1  1/25 (4.00%)  1
Hypertension G2 † 1  6/25 (24.00%)  7
Hypertension G3 † 1  3/25 (12.00%)  4
Hypotension G3 † 1  1/25 (4.00%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kristen Ganjoo, MD
Organization: Stanford University Medical Center
Phone: 650-725-6413
Responsible Party: Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier: NCT01391611     History of Changes
Other Study ID Numbers: IRB-20636
RR2002/00017/09 ( Other Identifier: GlaxoSmithKline )
11-311 ( Other Identifier: Stanford IRB alternate )
GIST0003 ( Other Identifier: OnCore )
First Submitted: July 8, 2011
First Posted: July 12, 2011
Results First Submitted: December 19, 2016
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017