Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cediranib | Drug | Cediranib | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Treatment A
- description
- Cediranib 20mg + Cisplatin + S-1
- interventionNames
- Drug: Cediranib
- Drug: Cisplatin
- Drug: S-1
- type
- OTHER
- label
- Treatment B
- description
- Cediranib 20mg + Cisplatin + Capecitabine
- interventionNames
- Drug: Cediranib
- Drug: Cisplatin
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available