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Completed

NCT Number: NCT00960349

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

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).

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cediranib

Drug

Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.

Cisplatin

Drug

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,

S-1

Drug

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

Capecitabine

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 17, 2009
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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