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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

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

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT00960349

First Posted

August 11, 2009

Last Updated

June 13, 2011

Sponsor

AstraZeneca

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

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

Time Frame

Cycle 1 and 2 of each treatment arm

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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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