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Trial record 1 of 3 for:    XL 820
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A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570635
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : June 7, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Drug: XL820 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Measures :
  1. Safety and tolerability of XL820 [ Time Frame: Assessed at each visit ]
  2. Progression-free survival, duration of response, and overall survival [ Time Frame: Assessed until progression ]
  3. Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST [ Time Frame: Assessed during periodic visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00570635

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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

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Responsible Party: Exelixis Identifier: NCT00570635     History of Changes
Other Study ID Numbers: XL820-201
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: May 2013

Keywords provided by Exelixis:
Gastrointestinal Cancer

Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors