CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
romidepsindrug
Likely dose
Romidepsin given intravenously (specific dose not stated in criteria or arms)AI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (excluding nasopharyngeal) that is unresectable or metastatic and incurable with surgery or radiation
  • ✓Measurable disease by RECIST criteria
  • ✓Tumor must be present at primary site and accessible to planned biopsy methods
  • ✓May have received any number of prior systemic chemotherapy regimens for unresectable, recurrent, or metastatic disease
Key exclusion· 8
  • ✕Prior therapy with depsipeptide
  • ✕Receiving other investigational agents or drugs with histone deacetylase inhibitor activity (e.g., sodium valproate)
  • ✕Known brain metastases
  • ✕Significant cardiac disease including congestive heart failure (NYHA class III-IV), myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina

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

Search/NCT00084682
NCT00084682Phase 2Completed
CompareCT.gov

A Phase II Study of Single Agent Depsipeptide (FK228; NSC 630176; IND 51,810) in Patients With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

National Cancer Institute (NCI)·interventional·Posted Jun 11, 2004·Updated Mar 5, 2021

In Brief

A Phase 2 clinical trial evaluating romidepsin for Stage IV Squamous Cell Carcinoma of the Hypopharynx and 3 related conditions. Completed, enrolled 14 participants across 2 sites.

Detailed Summary

This phase II trial is studying how well FR901228 works in treating patients with unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck. Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Oropharynx
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartJun 1, 2005
Primary CompletionNov 1, 2008
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 22.1 years ago

Interventions

romidepsindrug

Given IV