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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms

Intervention: Sunitinib, Pemetrexed, Cisplatin, Carboplatin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Aurora, Colorado 80045, United States

Pfizer Investigational Site, Ottawa, Ontario K1H 8L6, Canada

Pfizer Investigational Site, Montreal, Quebec H2L 4M1, Canada

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2006
Last updated: April 7, 2011

Page last updated: August 23, 2015

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