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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

December 7, 2007
May 30, 2013
December 2007
May 2009   (final data collection date for primary outcome 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 [ Time Frame: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00570635 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib
A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Neoplasms
  • Drug: XL820
    XL820 capsules administered orally as a single agent at a dose of 800 mg daily
  • Drug: XL820
    XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily
  • Experimental: A
    Intervention: Drug: XL820
  • Experimental: B
    Intervention: Drug: XL820
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00570635
XL820-201
Yes
Exelixis
Exelixis
Not Provided
Not Provided
Exelixis
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP