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

May 30, 2013 updated by: Exelixis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
    • Illinois
      • Park Ridge, Illinois, United States, 60068
    • Massachusetts
      • Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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: B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

June 7, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL820-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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