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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Gastric Cancer

Treatments: Drug: S-1; Drug: Capecitabine; Drug: Cediranib; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960349

D8480C00066

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Treatment A

Other group

Description:

Cediranib 20mg + Cisplatin + S-1

Treatment:

Drug: Cisplatin

Drug: Cediranib

Drug: Cisplatin

Drug: S-1

Treatment B

Other group

Description:

Cediranib 20mg + Cisplatin + Capecitabine

Treatment:

Drug: Cisplatin

Drug: Capecitabine

Drug: Cediranib

Drug: Cisplatin