Study Stopped
Lack of feasibility secondary to slow accrual
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
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
2 other identifiers
interventional
5
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2010
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
August 16, 2013
CompletedSeptember 9, 2013
August 1, 2013
1.4 years
December 11, 2009
June 12, 2013
August 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of Lesions for Progression or Response Via RECIST Criteria
Every 3 months
Study Arms (4)
Arm A
ACTIVE COMPARATORPatients with blood level less than 1100 will continue imatinib 400 mg daily
Arm B
ACTIVE COMPARATORPatients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Arm C
ACTIVE COMPARATORPatients with blood level ≥1100 will continue imatinib 400 mg daily
Arm D
ACTIVE COMPARATORPatients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Interventions
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Northwestern University
Chicago, Illinois, 60622, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52246, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
George S, Trent JC. The role of imatinib plasma level testing in gastrointestinal stromal tumor. Cancer Chemother Pharmacol. 2011 Jan;67 Suppl 1:S45-50. doi: 10.1007/s00280-010-1527-2. Epub 2010 Dec 8.
PMID: 21140148DERIVEDMarrari A, Trent JC, George S. Personalized cancer therapy for gastrointestinal stromal tumor: synergizing tumor genotyping with imatinib plasma levels. Curr Opin Oncol. 2010 Jul;22(4):336-41. doi: 10.1097/CCO.0b013e32833a6b8e.
PMID: 20489620DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A decision was made to discontinue the SARC019 trial effective March 3, 2011, due to lack of feasibility secondary to slow accrual. Due to early termination of the study, no patients were analyzed.
Results Point of Contact
- Title
- Research Project Manager
- Organization
- SARC
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne George, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2009
First Posted
December 14, 2009
Study Start
January 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 9, 2013
Results First Posted
August 16, 2013
Record last verified: 2013-08