A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: Sunitinib malate (SU011248)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457743

JapicCTI-070386

A6181045

Details and patient eligibility

About

Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Enrollment: 36 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
• Patients previously treated with imatinib mesylate.

Exclusion criteria

• Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
• Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

SU011248

Experimental group

Description:

25 , 50 or 75 mg/day of SU011248

Treatment:

Drug: Sunitinib malate (SU011248)