Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors
Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies
1 other identifier
interventional
43
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2005
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 3, 2007
CompletedFirst Posted
Study publicly available on registry
August 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 17, 2010
February 1, 2010
3.3 years
August 3, 2007
February 16, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination.
3 yrs
Study Arms (1)
1
EXPERIMENTALInterventions
AUC of 6 mg\*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Pfizer Investigational Site
Detroit, Michigan, 48201, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 3, 2007
First Posted
August 6, 2007
Study Start
November 1, 2005
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
February 17, 2010
Record last verified: 2010-02