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	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Gastrointestinal Stromal Tumor (GIST)
Intervention	Drug: Pazopanib
Enrollment	25

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Pazopanib Arm
Arm/Group Description	Pazopanib: 800 mg; PO
Arm/Group Description	Pazopanib: 800 mg; PO
Period Title: Overall Study
Started	25
Completed	3
Not Completed	22

Baseline Characteristics

Arm/Group Title		Pazopanib Arm
Arm/Group Description		Pazopanib: 800 mg; PO
Arm/Group Description		Pazopanib: 800 mg; PO
Overall Number of Baseline Participants		25
Baseline Analysis Population Description		[Not Specified]
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
United States		25

Outcome Measures

1.Primary Outcome


Title	Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)
Description	4-mo non-progression rat...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pazopanib Arm
Arm/Group Description:	Pazopanib: 800 mg; PO
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
Description	Response per Choi criter...
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

Outcome Measure Data

Analysis Population Description

Choi criteria measurements were not done due to technical difficulties.


Arm/Group Title	Pazopanib Arm
Arm/Group Description:	Pazopanib: 800 mg; PO
Arm/Group Description:	Pazopanib: 800 mg; PO
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

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
Arm/Group Description	Pazopanib: 800 mg; PO
Arm/Group Description	Pazopanib: 800 mg; PO
All-Cause Mortality
	Pazopanib Arm
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

More Information

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:	Kristen Ganjoo, MD
Organization:	Stanford University Medical Center
Phone:	650-725-6413
EMail:	kganjoo@stanford.edu

Layout table for additonal information

Responsible Party:	Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier:	NCT01391611
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

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