A Phase 1 interventional study of Cediranib and Cisplatin in Gastric Cancer, sponsored by AstraZeneca. Completed at 4 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-06-14.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 14 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
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Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Cediranib 20mg + Cisplatin + S-1
Drug: Cediranib · Drug: Cisplatin · Drug: S-1
Cediranib 20mg + Cisplatin + Capecitabine
Drug: Cediranib · Drug: Cisplatin · Drug: Capecitabine
Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.
Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
Also known as: Randa, Briplatin,
Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
Also known as: TS-1
60mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
Also known as: Randa, Briplatin
Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
Also known as: Xeloda
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
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.
Time frame: Cycle 1 and 2 of each treatment arm
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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