Clinical trial NCT00570635: A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib
Official title: A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Keywords: GIST
Gastrointestinal Cancer
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2007-12-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter
Secondary outcomes:
measure: Safety and tolerability of XL820
timeFrame: Assessed at each visit
measure: Progression-free survival, duration of response, and overall survival
timeFrame: Assessed until progression
measure: Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST
timeFrame: Assessed during periodic visits
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Park Ridge
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
Study officials:
References: