Back to resultsA Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib
Primary Purpose
Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XL820
XL820
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring GIST, Gastrointestinal Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Safety and tolerability of XL820
Progression-free survival, duration of response, and overall survival
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00570635
Brief Title
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
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exelixis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms
Keywords
GIST, Gastrointestinal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
XL820
Intervention Description
XL820 capsules administered orally as a single agent at a dose of 800 mg daily
Intervention Type
Drug
Intervention Name(s)
XL820
Intervention Description
XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily
Primary Outcome Measure Information:
Title
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
Time Frame
Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter
Secondary Outcome Measure Information:
Title
Safety and tolerability of XL820
Time Frame
Assessed at each visit
Title
Progression-free survival, duration of response, and overall survival
Time Frame
Assessed until progression
Title
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST
Time Frame
Assessed during periodic visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib
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