Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Cediranib
Cisplatin
S-1
Cisplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Japanese, PhI, Safety and tolerability, Cediranib in combination with cisplatin plus a fluoropyrimidine, Cediranib, Capecitabine, S-1, Cisplatin, Untreated locally advanced or metastatic unresectable gastric cancer (GC)
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction)
- Having locally advanced or metastatic gastric cancer for which they must have received no prior systemic therapy for locally advanced disease. Previous gastrectomy, neoadjuvant and adjuvant therapy received > 6 months ago are acceptable
- Having a mild symptom in ordinal daily lives including walking and simple labour or works in the sitting position
Exclusion Criteria:
- A history of poorly controlled hypertension or resting BP > 150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy or patients who are requiring maximal doses of calcium channel blockers to stabilize BP
- Significant Haemorrhage (> 30 ml bleeding/episode in previous 3 months) or haemoptysis (> 5 ml fresh blood in previous 4 weeks)
- Arterial thromboembolic event (including ischemic attack) in the previous 12 months
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Treatment A
Treatment B
Arm Description
Cediranib 20mg + Cisplatin + S-1
Cediranib 20mg + Cisplatin + Capecitabine
Outcomes
Primary Outcome Measures
Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
Secondary Outcome Measures
Pharmacokinetics will be assessed in terms of Css,max, Css,min, tmax, AUCss and AUC0-8 for cediranib, and Cmax, tmax, AUC, AUC(0-t), CL or CL/F, t½λz for capecitabine, cisplatin and TS-1. Additional PK parameters may be determined.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00960349
Brief Title
Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to assess the safety and tolerability of cediranib in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients with previously untreated locally advanced or metastatic unresectable gastric cancer (GC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, Japanese, PhI, Safety and tolerability, Cediranib in combination with cisplatin plus a fluoropyrimidine, Cediranib, Capecitabine, S-1, Cisplatin, Untreated locally advanced or metastatic unresectable gastric cancer (GC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Other
Arm Description
Cediranib 20mg + Cisplatin + S-1
Arm Title
Treatment B
Arm Type
Other
Arm Description
Cediranib 20mg + Cisplatin + Capecitabine
Intervention Type
Drug
Intervention Name(s)
Cediranib
Intervention Description
Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Randa, Briplatin,
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Randa, Briplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
Time Frame
Cycle 1 of each treatment arm
Secondary Outcome Measure Information:
Title
Pharmacokinetics will be assessed in terms of Css,max, Css,min, tmax, AUCss and AUC0-8 for cediranib, and Cmax, tmax, AUC, AUC(0-t), CL or CL/F, t½λz for capecitabine, cisplatin and TS-1. Additional PK parameters may be determined.
Time Frame
Cycle 1 and 2 of each treatment arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction)
Having locally advanced or metastatic gastric cancer for which they must have received no prior systemic therapy for locally advanced disease. Previous gastrectomy, neoadjuvant and adjuvant therapy received > 6 months ago are acceptable
Having a mild symptom in ordinal daily lives including walking and simple labour or works in the sitting position
Exclusion Criteria:
A history of poorly controlled hypertension or resting BP > 150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy or patients who are requiring maximal doses of calcium channel blockers to stabilize BP
Significant Haemorrhage (> 30 ml bleeding/episode in previous 3 months) or haemoptysis (> 5 ml fresh blood in previous 4 weeks)
Arterial thromboembolic event (including ischemic attack) in the previous 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narikazu Boku, MD
Organizational Affiliation
Shizuoka Cancer Center, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients
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