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

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ClinicalTrials.gov Identifier: NCT00960349
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Cediranib Drug: Cisplatin Drug: S-1 Drug: Capecitabine Phase 1

Study Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00960349     History of Changes
Other Study ID Numbers: D8480C00066
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: June 2011

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
Cediranib
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors