Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Stomach Neoplasms; Advanced Gastric Cancer

Treatments: Drug: cisplatin; Drug: axitinib; Drug: capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00842244

A4061055

Details and patient eligibility

About

The purpose of this study is to determine the safe and tolerable dose of axitinib given together with cisplatin and capecitabine in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of stomach cancer
• advanced stomach cancer of stage IV
• adequate blood chemistry, blood counts and kidney function
• willing to participate to study requirements and sign an informed consent document

Exclusion criteria

• prior chemotherapy for stomach cancer in its advanced stage
• excessive toxicities related to prior therapies
• pregnant or breastfeeding patients

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

A

Experimental group

Treatment:

Drug: cisplatin

Drug: axitinib

Drug: capecitabine