Trial Information

Summary: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec™, Glivec®)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.

This is a dual-arm, double-blind, placebo-controlled, multicenter, phase III clinical trial with 2:1 randomization evaluating the efficacy and safety of single-agent SU011248 as compared to placebo in patients with imatinib mesylate-resistant or intolerant malignant GIST.

Study medication refers to either SU011248 L-malate salt or placebo. SU011248 will be supplied in hard gelatin capsules while placebo will be supplied in hard gelatin capsules containing no SU011248.

The standardized RECIST method will be employed to evaluate tumor lesion size, using repeated radiographic assessment at 6-week intervals. Statistics will summarize all patient characteristics, treatment administration/ compliance, clinical benefit outcomes, pharmacokinetic variables and cancer biomarkers.

Inclusion / Exclusion Criteria
For consideration in the study, patients must have histopathologically-proven diagnosis of malignant GIST that is not amenable to surgery, radiation, or combined modality therapy with curative intent, and evidence of unidimensionally measurable disease.

Patients must not have had treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent after the last dose of imatinib mesylate. Also, patient must not have had imatinib mesylate-resistant disease with surgery, radiotherapy, and/or cryotherapy that affected all areas of measurable disease where progression on imatinib mesylate therapy had been demonstrated.

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Trial listings updated: June 1, 2008 at 5:43:58 AM