A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin
- Registration Number
- NCT00528619
- Lead Sponsor
- Pfizer
- Brief Summary
This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
- Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
- Patient has a good performance status (ECOG 0 or 1).
Exclusion Criteria
- Prior treatment with either pemetrexed or SU011248.
- Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
- Hypertension that cannot be controlled by medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Sunitinib, Pemetrexed, Cisplatin, Carboplatin -
- Primary Outcome Measures
Name Time Method To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin. From screening until at least 28 days beyond discontinuation of study treatment
- Secondary Outcome Measures
Name Time Method To evaluate the plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin when these drugs are co-administered. From screening until disease progression or discontinuation of the study To preliminarily assess the antitumor activity of SU011248 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma. From screening until disease progression or discontinuation of the study
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie SU011248's synergy with pemetrexed in advanced solid tumors?
How does sunitinib combination therapy compare to standard-of-care regimens in non-small cell lung cancer patients?
Which biomarkers correlate with response to sunitinib and pemetrexed in VEGFR/VEGFR2-targeted treatment strategies?
What are the dose-limiting toxicities of SU011248 with platinum-based chemotherapy in phase I trials?
How do multi-kinase inhibitors like SU011248 enhance pemetrexed efficacy in mesothelioma and other sarcomas?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇦Montreal, Quebec, Canada
Pfizer Investigational Site🇨🇦Montreal, Quebec, Canada