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A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

Phase 2
18 Years
Not Enrolling
Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms

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Trial Information

A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

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

- ECOG (Eastern Cooperative Oncology Group) performance status ≤2

- Must have measurable disease per RECIST (Response Evaluation Criteria in Solid

- 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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

May 2009

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Neoplasms
  • GIST
  • Gastrointestinal Cancer
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Stromal Tumors



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