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Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

NCT01728805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2024-04-25

Study results available
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Summary

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

Conditions

  • Cutaneous T-Cell Lymphoma

Interventions

BIOLOGICAL

KW-0761

1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

DRUG

Vorinostat

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Dmitri O. Grebennik, MD · Kyowa Kirin, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-03-31
Completion
2021-02-17

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

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 NCT01728805 on ClinicalTrials.gov