Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Conditions
Keywords
GIST, Gastrointestinal Cancer
Brief summary
The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.
Interventions
DRUGXL820
XL820 capsules administered orally as a single agent at a dose of 800 mg daily
Sponsors
Exelixis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib * ECOG (Eastern Cooperative Oncology Group) performance status ≤2 * Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors) * Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 or to subject's baseline status * Adequate organ and marrow function * Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs. * Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
Exclusion criteria
* Therapy with imatinib or sunitinib within 14 days before the first dose of study drug * Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib * Anticoagulation with warfarin or coumarin-related compounds * Radiation to ≥25% of bone marrow within 28 days of study entry * Treatment with other investigational agents within 28 days of the first dose of XL820 * Known central nervous systems metastases * Uncontrolled or intercurrent illness * Pregnancy or breast-feeding * Active bacterial or viral infection requiring systemic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib | Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of XL820 | Assessed at each visit |
| Progression-free survival, duration of response, and overall survival | Assessed until progression |
| Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST | Assessed during periodic visits |
Countries
United States
Outcome results
None listed