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

June 13, 2011 updated by: AstraZeneca

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
    • Osaka
      • Osakasayama, Osaka, Japan
        • Research Site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan
        • Research Site
    • Tokyo
      • Chuo, Tokyo, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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
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
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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Cycle 1 of each treatment arm

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Cycle 1 and 2 of each treatment arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Narikazu Boku, MD, Shizuoka Cancer Center, Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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