Status:
COMPLETED
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Lead Sponsor:
Pfizer
Conditions:
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00793871
Start Date
November 1 2008
End Date
October 1 2014
Last Update
November 20 2015
Active Locations (4)
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1
Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
2
Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC
Beijing, China, 100021
3
Beijing Cancer Hospital
Beijing, China, 100035
4
307 Hospital of PLA
Beijing, China, 100071