A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together

Pfizer

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Neoplasms; Solid Tumors

Treatments: Drug: SU011248; Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00618124

A6181044

Details and patient eligibility

About

This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
• Patient has good performance status (ECOG 0 or 1)

Exclusion criteria

• Prior treatment with either SU011248 or capecitabine.
• 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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77 participants in 1 patient group

A

Experimental group

Treatment:

Drug: SU011248; Capecitabine