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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00960349
First received: August 11, 2009
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Gastric Cancer
 Drug: Cediranib
Drug: Cisplatin
Drug: S-1
Drug: Capecitabine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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. [ Time Frame: Cycle 1 of each treatment arm ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Cycle 1 and 2 of each treatment arm ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TS-1
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 Name: 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 Name: Xeloda

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960349

Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Osakasayama, Osaka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Chuo, Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Narikazu Boku, MD Shizuoka Cancer Center, Japan
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00960349     History of Changes
Other Study ID Numbers: D8480C00066
Study First Received: August 11, 2009
Last Updated: June 13, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
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)

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Fluorouracil
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 13, 2013