Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events

Outcome Description:

Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.

Outcome Time Frame:

Up to 795 days of treatment plus 28-days follow-up

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

A4061022

NCT ID:

NCT00447005

Start Date:

February 2007

Completion Date:

August 2009

Related Keywords:

• Carcinoma
• Safety
• PK
• Biomarker
• Carcinoma