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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528619

A6181084

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin