Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients

Phase 1

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Cediranib; Drug: Cisplatin; Drug: S-1; Drug: Capecitabine

• Registration Number: NCT00960349
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2010-01
• Study Completion: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A	Cediranib	Cediranib 20mg + Cisplatin + S-1
Treatment A	Cisplatin	Cediranib 20mg + Cisplatin + S-1
Treatment A	S-1	Cediranib 20mg + Cisplatin + S-1
Treatment B	Cisplatin	Cediranib 20mg + Cisplatin + Capecitabine
Treatment B	Capecitabine	Cediranib 20mg + Cisplatin + Capecitabine
Treatment B	Cediranib	Cediranib 20mg + Cisplatin + Capecitabine

Primary Outcome Measures

Name	Time	Method
Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.	Cycle 1 of each treatment arm

Secondary Outcome Measures

Name	Time	Method
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.	Cycle 1 and 2 of each treatment arm

Trial Locations

Locations (1)

Research Site; 🇯🇵 Chuo, Tokyo, Japan