Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT00570635
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00570635
Study Brief:
Protocol Section:
NCT00570635