NCT00511849CompletedPhase 1
Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
1
Experimental
Intervention: carboplatin + SU011248 (sunitinib) + paclitaxel (Drug)
Outcomes
Primary Outcomes
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)
Time Frame: 3 yrs
Secondary Outcomes
- Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination.(3 yrs)
Investigators
Study Sites (1)
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