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

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00570635

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms	Drug: XL820	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

Further study details as provided by Exelixis:

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 [ Time Frame: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of XL820 [ Time Frame: Assessed at each visit ] [ Designated as safety issue: Yes ]
Progression-free survival, duration of response, and overall survival [ Time Frame: Assessed until progression ] [ Designated as safety issue: No ]
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
A: Experimental	Drug: XL820 XL820 capsules administered orally as a single agent at a dose of 800 mg daily
B: Experimental	Drug: XL820 XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570635

Locations

United States, California

Los Angeles, California, United States, 90095
United States, Illinois

Park Ridge, Illinois, United States, 60068
United States, Massachusetts

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Exelixis

More Information

Responsible Party:	Exelixis, Inc. ( Salim Yazji, MD, Director, Clinical Research )
Study ID Numbers:	XL820-201
Study First Received:	December 7, 2007
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00570635
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

GIST
Gastrointestinal Cancer

Study placed in the following topic categories:

Imatinib
Digestive System Diseases
Digestive System Neoplasms
Sunitinib

Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009