Trials / Completed
CompletedNCT00842244
Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer
A Phase 1 Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | axitinib | Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
| DRUG | capecitabine | Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m\^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
| DRUG | cisplatin | Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m\^2 on day 1. |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2009-12-01
- Completion
- 2012-10-01
- First posted
- 2009-02-12
- Last updated
- 2013-11-27
- Results posted
- 2012-03-26
Locations
5 sites across 2 countries: Japan, South Korea
Source: ClinicalTrials.gov record NCT00842244. Inclusion in this directory is not an endorsement.