A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasm, Malignant

Treatments: Drug: Sunitinib, Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00732992

A6181165

Details and patient eligibility

About

This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of a solid malignancy that is refractory to standard therapy or for which no standard therapy exists.
• Patients 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 okey).
• Hypertension that cannot be controlled by medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

CDD

Experimental group

Treatment:

Drug: Sunitinib, Pemetrexed

Drug: Sunitinib, Pemetrexed

2/1

Experimental group

Treatment:

Drug: Sunitinib, Pemetrexed

Drug: Sunitinib, Pemetrexed