CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
romidepsin +2 moredrug
Likely dose
Romidepsin administered intravenously (specific dose not stated in provided text)AI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed non-medullary thyroid carcinoma (papillary, follicular, or Hürthle cell variants)
  • ✓Recurrent and/or metastatic disease
  • ✓At least 1 unidimensionally measurable lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • ✓Progressive disease demonstrated by new/progressive lesions, rising thyroglobulin with ≥3 consecutive rises (≥1 week apart), or new bone/PET lesions
Key exclusion· 8
  • ✕Known brain metastases
  • ✕Prior depsipeptide (FR901228) therapy
  • ✕Prior cytotoxic chemotherapy (unless used as radiosensitizer >3 months prior)
  • ✕Cardiac history: CCS class II-IV angina, MI within 12 months, sustained ventricular arrhythmias, cardiac arrest, Mobitz II block without pacemaker, uncontrolled hypertension (≥160/95), or congenital long QT syndrome

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

Search/NCT00098813
NCT00098813Phase 2Completed
CompareCT.gov

A Phase II Study of Single Agent Depsipeptide (FK228) in Radioiodine (RAI)-Refractory Metastatic Non-medullary (Papillary, Follicular, and Hurthle Cell Variants) Thyroid Carcinoma

National Cancer Institute (NCI)·interventional·Posted Dec 9, 2004·Updated May 28, 2014

In Brief

A Phase 2 clinical trial evaluating romidepsin, laboratory biomarker analysis, and 1 other intervention for Recurrent Thyroid Cancer and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This phase II trial is studying how well romidepsin works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine. Romidepsin may stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. It may also help radioactive iodine and chemotherapy work better by making tumor cells more sensitive to the drug

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2004
Enrollment StartOct 1, 2004
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 21.6 years ago

Interventions

romidepsindrug

Given IV

laboratory biomarker analysisother

Correlative studies

positron emission tomographyprocedure

Correlative studies