A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Solid Tumors
- Interventions
- Drug: SU011248; Gemcitabine
- Registration Number
- NCT00615446
- Lead Sponsor
- Pfizer
- Brief Summary
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
- Patient has good performance status (ECOG 0 or 1)
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Exclusion Criteria
- Prior treatment with either gemcitabine or SU011248
- Hypertension that cannot be controlled by medications
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A SU011248; Gemcitabine -
- Primary Outcome Measures
Name Time Method To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine From screening until at least 28 days beyond discontinuation of study treatment
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered From screening until at least 28 days beyond discontinuation of study treatment To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease From screening until at least 28 days beyond discontinuation of study treatment
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Boston, Massachusetts, United States