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

NCT01391611 | Terminated Phase 2 Results DMC

• 4 other identifiers: IRB-20636RR2002/00017/0911-311GIST0003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being done to gather information about the safety (any harmful effects) and effectiveness (usefulness) of Pazopanib in the treatment of Gastrointestinal Stroma Tumors (GIST) that cannot be treated by surgery or has spread to other organs. The Food and Drug Administration (FDA) have approved Pazopanib for the treatment of advanced kidney cancer but it is not approved for the treatment of GIST. The investigators hope to learn about the safety and usefulness (effectiveness) of Pazopanib for patients with GIST. Primary Objective: Non-progression rate based on RECIST criteria (CR+PR+SD) Secondary Objectives:

• Response per Choi criteria
• 6 month progression-free survival
• Safety and tolerability

Conditions

Gastrointestinal Stromal Tumor (GIST)

Outcome Measures

Primary Outcomes (1)

• Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)

  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

  24 weeks

Secondary Outcomes (1)

• Response Per Choi Criteria

  6 months

Study Arms (1)

Pazopanib arm

EXPERIMENTAL

Drug: Pazopanib

Interventions

Pazopanib DRUG

800 mg; PO

Also known as: Votrient

Pazopanib arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic or unresectable gastrointestinal stromal tumor (GIST)
• Failure or intolerance to Imatinib and sunitinib
• Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
• Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
• Age \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Measurable disease criteria by RECIST criteria
• Adequate organ system function as defined in protocol.
• A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant). This includes any female who has had:
• A hysterectomy
• A bilateral oophorectomy (ovariectomy)
• A bilateral tubal ligation
• Menopause
• Childbearing potential females must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agree to use adequate contraception. Adequate acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
• An intrauterine device with a documented failure rate of less than 1% per year.

You may not qualify if:

• History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
• Clinically significant gastrointestinal abnormalities that may affect absorption of the investigational product
• Presence of uncontrolled infection
• Prolongation of corrected QT interval (QTc) \> 480 milliseconds. On antiarrhythmics or medications known to prolong QT interval
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting
• Myocardial infarction
• Unstable angina
• Coronary artery by-pass graft surgery
• Symptomatic peripheral vascular disease
• Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
• Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of \>=140 mmHg or diastolic blood pressure (DBP) of \>= 90mmHg\].
• History of cerebrovascular accident, hemoptysis, cerebral hemorrhage, clinically significant GI bleed, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
• Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture
• Evidence of active bleeding or bleeding diathesis.

Sponsors & Collaborators

• Kristen Ganjoo: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Kristen Ganjoo, MD
• Organization: Stanford University Medical Center

kganjoo@stanford.edu

650-725-6413

Study Officials

• Kristen N. Ganjoo

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2016-12

Locations

US (2)