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A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL)

NCT01456039 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-02-11

Study results available
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Summary

The purpose of the study was to assess efficacy, tolerability, safety and pharmacokinetics of Romidepsin in subjects with progressive or relapsed peripheral T-cell lymphoma

Conditions

  • Lymphoma, T-cell, Peripheral

Interventions

DRUG

Romidepsin

Intravenous dosing for 4 hours on Days 1, 8, and 15 of each 28-day cycle

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Toru Sasaki · Celgene K.K.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2015-07-28
Completion
2018-12-14

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456039 on ClinicalTrials.gov