Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
Outcome Time Frame:
Cycle 1 of each treatment arm
Safety Issue:
Yes
Principal Investigator
Narikazu Boku, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Shizuoka Cancer Center, Japan
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
D8480C00066
NCT ID:
NCT00960349
Start Date:
August 2009
Completion Date:
March 2011
Related Keywords:
- Gastric Cancer
- 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)
- Stomach Neoplasms