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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Cediranib
* Drug: Cisplatin
* Drug: S-1
* Drug: Cisplatin
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment A<br>Cediranib 20mg + Cisplatin + S-1 | Drug: Cediranib<br>* Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.<br>Drug: Cisplatin<br>* 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.<br>* Other names: Randa, Briplatin,;Drug: S-1<br>* 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.<br>* Other names: TS-1;|
| Other: Treatment B<br>Cediranib 20mg + Cisplatin + Capecitabine | Drug: Cediranib<br>* Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.<br>Drug: Cisplatin<br>* 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.<br>* Other names: Randa, Briplatin;Drug: Capecitabine<br>* 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.<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)