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

This study has been terminated.

( Lack of feasibility secondary to slow accrual )

First Received on December 11, 2009. Last Updated on July 20, 2011 History of Changes

Sponsor:	Sarcoma Alliance for Research through Collaboration
Collaborator:	Novartis Pharmaceuticals
Information provided by:	Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:	NCT01031628

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: Imatinib mesylate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Sarcoma Alliance for Research through Collaboration:

Primary Outcome Measures:

Evaluation of lesions for progression or response via RECIST criteria [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	January 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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 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
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, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops Other Names: Gleevec Glivec

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031628

Locations

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

Sponsors and Collaborators

Sarcoma Alliance for Research through Collaboration

Novartis Pharmaceuticals

Investigators

Principal Investigator:

Suzanne George, MD

Dana-Farber Cancer Institute

More Information

Additional Information:

SARC Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Denise Reinke, MS, NP, SARC
ClinicalTrials.gov Identifier:	NCT01031628 History of Changes
Other Study ID Numbers:	SARC019, STI571BUS286T
Study First Received:	December 11, 2009
Last Updated:	July 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Sarcoma Alliance for Research through Collaboration:

GIST
Gastrointestinal stromal tumors
Exon 9
Gleevec
Imatinib blood levels

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012