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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00960349 |
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Date of registration:
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11/08/2009 |
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Primary sponsor: |
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Public title:
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Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients
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Scientific 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 |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00960349 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Narikazu Boku, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shizuoka Cancer Center, Japan |
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Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastric Cancer
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Intervention(s)
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Drug: Capecitabine
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Drug: Cediranib
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Drug: Cisplatin
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Drug: S-1
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Primary Outcome(s)
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Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
[Time Frame: Cycle 1 of each treatment arm]
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Secondary Outcome(s)
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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, t½?z for capecitabine, cisplatin and TS-1. Additional PK parameters may be determined.
[Time Frame: Cycle 1 and 2 of each treatment arm]
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Secondary ID(s)
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D8480C00066
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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