Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Registration Number
- NCT00511849
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent
- Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens
- ECOG performance status 0 or 1
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Exclusion Criteria
- Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions
- Diagnosis of any second malignancy within the past 3 years
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 carboplatin + SU011248 (sunitinib) + paclitaxel -
- Primary Outcome Measures
Name Time Method Determination of the maximum tolerated dose (MTD) and overall safety of SU011248 when administered in combination with paclitaxel/carboplatin in patients with advanced solid tumors (ongoing) 3 yrs
- Secondary Outcome Measures
Name Time Method Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination. 3 yrs
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Madison, Wisconsin, United States