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

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-12
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

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).

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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.

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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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Montreal, Quebec, Canada