Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors

Treatments: Drug: Sunitinib Malate (SU011248)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793871

A6181177

Details and patient eligibility

About

To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
• Evidence of unidimensionally measurable disease
• Failure of prior treatment with imatinib or intolerant to imatinib
• Male or female, 18 years of age or older.
• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
• Resolution of all acute toxic effects
• Adequate organ function.

Exclusion criteria

• Anticancer treatment after last dose of imatinib
• Major surgery within 4 weeks or radiation therapy within 2 weeks.
• Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
• Diagnosis of second malignancy within the last 5 years.
• History of brain disease.
• Cardiac disease within 12 months.
• Thyroid function abnormality.
• Ongoing cardiac dysrhythmias.
• Uncontrolled hypertension.
• Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
• HIV or AIDS related illness.
• Pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

sunitinib

Experimental group

Description:

single agent sunitinib, single arm

Treatment:

Drug: Sunitinib Malate (SU011248)