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

Stopped early · Phase 3

Conditions studied: Gastrointestinal Stromal Tumors

In brief

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.

Key facts

Study ID

NCT01031628

Run by

Sarcoma Alliance for Research through Collaboration

People needed

5

Starts

2010-01-01

Expected to finish

2011-06-01

Last updated by the study team

2013-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cedars-Sinai Outpatient Cancer Center — Los Angeles, California, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Carolinas Hematology Oncology Associates — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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