Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
NCT00793871
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor | |||
| Official Title ICMJE | A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate | |||
| Brief Summary | To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors | |||
| Intervention ICMJE | Drug: Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg. | |||
| Study Arms ICMJE | Experimental: sunitinib
single agent sunitinib, single arm Intervention: Drug: Sunitinib Malate (SU011248) | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 60 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | October 2014 | |||
| Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00793871 | |||
| Other Study ID Numbers ICMJE | A6181177 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||