Skip to main content
OpenTrials
Completed

NCT Number: NCT00570635

A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XL820

Drug

XL820 capsules administered orally as a single agent at a dose of 800 mg daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study title

A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 11, 2007
Registry last updated
Jun 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.