Asian Phase I Study Of PF-03446962

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: PF-03446962

Study type: Interventional

Funder types: Industry

Identifiers

NCT01337050

A8471004

Details and patient eligibility

About

This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose [MTD] and the Recommended Phase 2 Dose [RP2D].

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of stomach cancer
• advanced/metastasis solid tumor refractory or intolerant to established therapy
• adequate blood chemistry, blood counts and kidney/liver function
• willing to participate to study requirements and sign an informed consent document

Exclusion criteria

• Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
• excessive toxicities related to prior therapies
• pregnant or breastfeeding patients

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

A

Experimental group

Description:

PF-03446962

Treatment:

Drug: PF-03446962