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

Gastrointestinal Stromal Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01031628
• Other study ID #: SARC019
• Secondary ID: STI571BUS286T
• Status: Terminated
• Phase: Phase 3
• First received: December 11, 2009
• Last updated: August 22, 2013
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2013
• Source: Sarcoma Alliance for Research through Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Imatinib mesylate
400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
• Imatinib mesylate
600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
• Imatinib mesylate
400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Sarcoma Alliance for Research through Collaboration	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Lesions for Progression or Response Via RECIST Criteria		Every 3 months	No

External Links

•   SARC Website