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

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: Gastric Cancer
• Intervention / Treatment: Drug: Cediranib; Drug: Cisplatin; Drug: S-1; Drug: Cisplatin; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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.	Cycle 1 and 2 of each treatment arm

Collaborators and Investigators

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

Study record dates

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: Capecitabine; Gastric cancer; Cisplatin; Japanese; S-1; Safety and tolerability; Cediranib; PhI; Cediranib in combination with cisplatin plus a fluoropyrimidine; Untreated locally advanced or metastatic unresectable gastric cancer (GC)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Cisplatin; Capecitabine; Cediranib
• Other Study ID Numbers: D8480C00066