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A Phase 2 Study of Trastuzumab in Combination With TS-ONE and Cisplatin in Firstline Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

NCT01736410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-06-17

No results posted yet for this study

Summary

To explore overall response rate of trastuzumab combined with TS-ONE based chemotherapy in first-line HER2-positive advanced gastric cancer.

Conditions

  • HER 2 Positive Advanced Gastric Cancer

Interventions

DRUG

Trastuzumab, TS ONE, Cisplatin

The initial dose of cisplatin is fixed to be 60 mg/m2 and intravenously administered over 1 hour on day 1 of the cycle. TS-ONE is orally administered consecutive 14-day followed by 7-day rest. The initial standard dose of TS-ONE is determined based on the body surface area tabled below. Trastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by HER2-positive advanced GC 21 years or older No prior regimen HER2 protein HER2/neu detection procedure Tissue from (Gastric) Cancer FISH method IHC method negative positive HER-2 negative HER-2 positive Eligible 0 / 1+ 2+ 3+ HER-2 positive Eligible HER-2 negative iii Protocol S1/CDDP/Her V1.3 dated 21 May 10 maintenance dose of 6mg/kg in day 1 of each cycle. The study treatments are repeated every 3 weeks. Study treatment can continue until PD, but cisplatin can be skipped or discontinued if patients experienced unbearable toxicity which comes from cisplatin.

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Choo Su Pin · National Cancer Centre, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736410 on ClinicalTrials.gov