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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00960349

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Cediranib Drug: Cisplatin Drug: S-1 Drug: Cisplatin Drug: Capecitabine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: Xeloda

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

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 Names:

Xeloda

Outcome Measures

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. [Cycle 1 of each treatment arm]

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. [Cycle 1 and 2 of each treatment arm]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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