NCT01045538

Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer: Zolinza+XP

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Histone Deacetylase Inhibitor

Interventions

Type	Name	Description
DRUG	Vorinostat, capecitabine, and cisplatin	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

Timeline

• Start date: 2010-02-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2010-01-11
• Last updated: 2020-01-07

Locations

1 site across 1 country: South Korea