Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Gastrointestinal Stromal Tumor

Treatments: Drug: sunitinib malate; Drug: imatinib mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372567

A6181112

Details and patient eligibility

About

A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

Full description

The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

Exclusion criteria

• Current treatment with any chemotherapy other than imatinib.
• Current treatment with any dose of imatinib other than 400 mg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: sunitinib malate

B

Active Comparator group

Treatment:

Drug: imatinib mesylate