CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Vorinostat, capecitabine, and cisplatindrug
Likely dose
Vorinostat, capecitabine, and cisplatin 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01045538
NCT01045538Phase 2Completed
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A Phase I/II Study of Vorinostat (Zolinza®) in Combination With Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer

Asan Medical Center·interventional·Posted Jan 11, 2010·Updated Jan 7, 2020

In Brief

A Phase 2 clinical trial evaluating Vorinostat, capecitabine, and cisplatin for Gastric Cancer and Histone Deacetylase Inhibitor. Completed, enrolled 45 participants across 1 site.

Detailed Summary

There is scientific rationale for exploring the role of vorinostat, histone deacetylase inhibitor with capecitabine (X) and cisplatin (P), one of standard chemotherapy in patients with advanced gastric cancer. XP is a new standard of care in advanced gastric cancer (AGC) and vorinostat is a novel targeted agent that prevents tumor cell proliferation, survival and angiogenesis through histone deacetylase inhibition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Histone Deacetylase Inhibitor
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2010
Enrollment StartFeb 1, 2010
Primary CompletionFeb 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 16.5 years ago

Interventions

Vorinostat, capecitabine, and cisplatindrug

Vorinostat 200\~400mg per day on day1-day14 combined with capecitabine 800-1,000mg/m2/dose, BID on day1-day14, and cisplatin 60-80mg/m2 on day 1