Clinical trial NCT00960349: Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Cancer
Keywords: 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)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
timeFrame: Cycle 1 of each treatment arm
Secondary outcomes:
measure: 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.
timeFrame: Cycle 1 and 2 of each treatment arm
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
Study officials:
affiliation: Shizuoka Cancer Center, Japan
name: Narikazu Boku, MD
role: PRINCIPAL_INVESTIGATOR
References: