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Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL

NCT02757248 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-12-01

No results posted yet for this study

Summary

This is a phase I study of the combination of volasertib and romidepsin in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) or stage IIB-IV cutaneous T cell lymphoma (CTCL). This study will determine the maximum tolerated dose (MTD) of this combination by treating cohorts of patients at a certain dose combination. The investigators will use a Bayesian design to determine the dose combination for the next cohort of patients and to determine the MTD. Overall response rate as well as adverse events will be monitored and reported.

Conditions

Interventions

DRUG

Volasertib

Volasertib 75-150mg/m2 given intravenously on days 1 and 8

DRUG

Romidepsin

Romidepsin 12-14mg/m2 given intravenously on days 1, 8 and 15

Sponsors & Collaborators

Principal Investigators

  • Anne w Beaven, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

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Entities

Diseases
Companies

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 NCT02757248 on ClinicalTrials.gov