A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Stromal Tumor

Treatments: Drug: Placebo; Drug: SU011248

Study type: Interventional

Funder types: Industry

Identifiers

NCT00075218

A6181004

Details and patient eligibility

About

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.

Enrollment: 361 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
• Failed Gleevec treatment or intolerant to Gleevec therapy

Key Exclusion Criteria:

• Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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361 participants in 2 patient groups, including a placebo group

B

Placebo Comparator group

Treatment:

Drug: Placebo

A

Active Comparator group

Treatment:

Drug: SU011248