CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Vorinostat +1 moredrug
Likely dose
Vorinostat 200 mgfrom 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/NCT00821951
NCT00821951Phase 1Completed
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A Dose Escalation Study of Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer

Yale University·interventional·Posted Jan 14, 2009·Updated Nov 20, 2020

In Brief

A Phase 1 clinical trial evaluating Vorinostat and Radiotherapy for Non-Small Cell Lung Cancer (NSCLC). Completed, enrolled 17 participants across 1 site.

Detailed Summary

This is a dose escalation study that will assess the safety of Vorinostat, a Histone Deacetylase (HDAC) inhibitor, in combination with palliative radiotherapy in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Vorinostat has been approved for use in patients with cutaneous T-cell lymphomas, but several pre-clinical studies suggest activity in lung cancer cell lines. Several HDAC inhibitors,including Vorinostat, may enhance the effect of radiotherapy, and this study will seek to confirm this.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer (NSCLC)
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2009
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.5 years ago

Interventions

Vorinostatdrug

200 mg, 300 mg, 400 mg, once per RT fraction

Radiotherapyradiation

Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.