Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients

August 22, 2013 updated by: Sarcoma Alliance for Research through Collaboration

A Randomized, Phase 3 Study of Dose Escalation Versus No Dose Escalation of Imatinib In Metastatic GIST Patients With Imatinib Trough Levels Less Than 1100 Nanograms/mL

The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

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, 90048
        • Cedars-Sinai Outpatient Cancer Center
      • Santa Monica, California, United States, 90403
        • Sarcoma Oncology Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • University of Iowa
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Hematology Oncology Associates
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

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:

  • Age ≥ 18 years
  • Unresectable and/or metastatic GIST
  • Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
  • For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
  • Good physical functioning (ECOG Performance Status of 0 or 1)
  • Generally, good function of organ such as liver and kidneys

Exclusion Criteria:

  • Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
  • Known intolerance of imatinib at a dose of 400 mg/day or higher
  • Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
  • Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
  • Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
  • Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks or who have not recovered from side effects of this therapy

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Patients with blood level less than 1100 will continue imatinib 400 mg daily
Drug: Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Active Comparator: Arm B
Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Drug: Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Active Comparator: Arm C
Patients with blood level ≥1100 will continue imatinib 400 mg daily
Drug: Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Active Comparator: Arm D
Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Drug: Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec
Drug: Imatinib mesylate
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Other Names:
  • Gleevec
  • Glivec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Lesions for Progression or Response Via RECIST Criteria
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

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

Sponsor

Sarcoma Alliance for Research through Collaboration

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Suzanne George, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 11, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARC019
  • STI571BUS286T

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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