study of Cediranib plus Cisplatin plus Capecitabine/S-1 in Japanese gastric cancer patients
Study identifier:D8480C00066
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-label, Non-randomized Study, to assess the Safety and Tolerability of Cediranib (AZD2171) in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients with Previously Untreated Locally Advanced or Metastatic Unresectable Gastric Cancer
Medical condition
gastric cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
Cediranib, Cisplatin, S-1, Capecitabine
Sex
All
Actual Enrollment
14
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: 01 Jan 2010
Study Completion Date: 01 Mar 2011
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Other: Treatment A Cediranib 20mg + Cisplatin + S-1 | Drug: Cediranib Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion. Drug: Cisplatin Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given. Other Name: Randa, Briplatin, Drug: S-1 Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion. Other Name: TS-1 |
| Other: Treatment B Cediranib 20mg + Cisplatin + Capecitabine | Drug: Cediranib Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion. Drug: Cisplatin 60mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given. Other Name: Randa, Briplatin Drug: Capecitabine Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion. Other Name: Xeloda |
Contacts
Investigators
Principal Investigator
Narikazu Boku
Shizuoka Cancer Center, Japan
