CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
romidepsindrug
Likely dose
Romidepsin 13 mg/m² IV infusion over 4 hoursAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed soft tissue sarcoma including GIST (if refractory to imatinib), desmoplastic small round cell tumors, clear cell sarcoma, extraskeletal osteosarcoma, extraskeletal Ewing's sarcoma, or extraskeletal chondrosarcoma
  • ✓Metastatic or unresectable disease
  • ✓No standard curative therapy exists
  • ✓Measurable disease: ≥1 lesion ≥20 mm by conventional imaging OR ≥10 mm by spiral CT
Key exclusion· 6
  • ✕Brain metastases
  • ✕Cardiac abnormalities including congenital long QT syndrome, myocardial infarction within past year, coronary artery disease, cardiac ischemia, heart failure (NYHA Class II-IV), sustained ventricular arrhythmias, cardiomyopathy, significant left ventricular hypertrophy, uncontrolled hypertension, or arrhythmia requiring anti-arrhythmic medication
  • ✕Prior FR901228 (depsipeptide)
  • ✕More than 1 prior chemotherapy regimen for sarcoma (GIST exception: up to 3 regimens of imatinib/sunitinib)

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

Search/NCT00112463
NCT00112463Phase 2Completed
CompareCT.gov

A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas

National Cancer Institute (NCI)·interventional·Posted Jun 3, 2005·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating romidepsin for Adult Alveolar Soft-part Sarcoma and 19 related conditions. Completed, enrolled 40 participants.

Detailed Summary

This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Extraskeletal Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Fibrous Histiocytoma, Adult Malignant Hemangiopericytoma, Adult Malignant Mesenchymoma, Adult Neurofibrosarcoma, Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Gastrointestinal Stromal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Adult Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2005
Enrollment StartJan 7, 2005
Primary CompletionOct 23, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.1 years ago

Interventions

romidepsindrug

DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.