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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT00570635
First received: December 7, 2007
Last updated: May 30, 2013
Last verified: May 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ]

Enrollment: 16
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: XL820
XL820 capsules administered orally as a single agent at a dose of 800 mg daily
Experimental: B 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

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT00570635     History of Changes
Other Study ID Numbers: XL820-201
Study First Received: December 7, 2007
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
GIST
Gastrointestinal Cancer

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Stromal Tumors
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sunitinib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013