A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib

Exelixis

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms

Treatments: Drug: XL820

Study type: Interventional

Funder types: Industry

Identifiers

NCT00570635

XL820-201

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: XL820

Drug: XL820

B

Experimental group

Treatment:

Drug: XL820

Drug: XL820