Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)

Outcome Description:

DLT includes: Grade (GR) 2 proteinuria; GR3 nonhematological toxicity (NHT) (excluding alopecia and those that can be controlled with appropriate treatment) for greater than or equal to (>=)7 days, GR3 thrombocytopenia with active bleeding; GR>=3 febrile neutropenia (NP) or NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment related toxicity with >3 consecutive capecitabine or 5 consecutive axitinib missed doses per cycle; delayed toxicity recovery >14 days.

Outcome Time Frame:

Baseline up to Day 21 of Cycle 1

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061055

NCT ID:

NCT00842244

Start Date:

April 2009

Completion Date:

October 2012

Related Keywords:

• Stomach Neoplasms
• Advanced Gastric Cancer
• Neoplasms
• Stomach Neoplasms