NCT00555620

Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	capecitabine	Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.
DRUG	oxaliplatin	Oxaliplatin is given 110mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
DRUG	sunitinib malate	sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
DRUG	capecitabine	Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.
DRUG	cisplatin	Cisplatin is given 80mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
DRUG	sunitinib malate	sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-08-01
• Completion: 2011-12-01
• First posted: 2007-11-08
• Last updated: 2013-01-14
• Results posted: 2011-09-05

Locations

3 sites across 1 country: South Korea