Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors

Pfizer

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: PF-03814735

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424632

A9491001

Details and patient eligibility

About

The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic solid tumor resistant to standard therapy or for which no standard therapy is available
• Adequate bone marrow, liver and kidney function

Exclusion criteria

• Brain metastases that are symptomatic and/or require treatment with steroids and/or anticonvulsants, or brain metastases that have been treated within 3 months prior to study start
• Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Single arm dose escalation

Experimental group

Treatment:

Drug: PF-03814735