CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
vorinostatdrug
Likely dose
Vorinostat 400 mg orally once daily for 4 weeks, repeating every 4 weeksAI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed melanoma that is metastatic or unresectable
  • Measurable disease: at least 1 lesion ≥20 mm (conventional) or ≥10 mm (spiral CT) within 4 weeks prior to enrollment
  • No prior therapy or 1 prior treatment (cytokine/chemotherapy/combination) for metastatic disease
  • Age ≥18 years
Key exclusion· 7
  • Known brain metastases
  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment
  • Currently receiving any other investigational agents
  • History of allergic reactions to compounds of similar chemical or biologic composition to vorinostat

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

Search/NCT00121225
NCT00121225Phase 2Completed

A Phase II Study of Vorinostat in Patients With Advanced Melanoma

National Cancer Institute (NCI)·interventional·Posted Jul 21, 2005·Updated Jan 29, 2019

In Brief

A Phase 2 clinical trial evaluating vorinostat for Ciliary Body and Choroid Melanoma, Medium/Large Size and 6 related conditions. Completed, enrolled 32 participants across 5 sites in 2 countries.

Detailed Summary

This phase II trial is studying how well vorinostat works in treating patients with metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2005
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2009
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.9 years ago

Interventions

vorinostatdrug

Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.