A Single-Arm, Open-Label, Multi-Center, Phase IV, Safety And Efficacy Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Imatinib Mesylate-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Both
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Trial Information
A Single-Arm, Open-Label, Multi-Center, Phase IV, Safety And Efficacy Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Imatinib Mesylate-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free Survival (PFS)
Outcome Time Frame:
from enrollment to disease progress or death
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
China: Food and Drug Administration
Study ID:
A6181177
NCT ID:
NCT00793871
Start Date:
November 2008
Completion Date:
July 2013
Related Keywords:
- Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
- sunitinib
- Phase IV
- gastrointestinal stomal tumor
- imatinib resistant or intolerant
- Chinese
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Stromal Tumors
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