NCT02757248

Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL

A Phase I Trial of Volasertib Plus Romidepsin in Patients With Relapsed/Refractory Peripheral T Cell and Cutaneous T Cell Lymphoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Anne Beaven, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-randomized, unblinded single arm Phase I multi-center trial to determine the maximum tolerated dose (MTD) of the combination of volasertib and romidepsin in patients with relapsed/refractory peripheral T cell (PTCL) and cutaneous T cell (CTCL) lymphoma. Primary Objectives: 1\. Determine the maximum tolerated dose (MTD) of the combination of romidepsin and volasertib in patients with relapsed/refractory peripheral T cell and cutaneous T cell lymphoma. Secondary Objectives: 1. Evaluate the overall response rate (ORR) to the combination of romidepsin and volasertib in patients with relapsed/refractory peripheral T cell and cutaneous t cell lymphoma. 2. Define gene expression signatures and patterns of acquired tumor mutations that dynamically correlate to clinical response to romidepsin/volasertib combination therapy in cutaneous T cell lymphoma (CTCL) through longitudinal RNA sequencing of tumor samples. Dose Combinations (-1): Volasertib 50mg/m2 Days 1 \& 8; Romidepsin 10mg/m2 Days 1, 8 \& 15 (1-starting dose): Volasertib 75mg/m2 Days 1 \& 8; Romidepsin 12mg/m2 Days 1, 8 \& 15 (2): Volasertib 100mg/m2 Days 1 \& 8; Romidepsin 12mg/m2 Days 1, 8 and 15 (3): Volasertib 100mg/m2 Days 1 \& 8; Romidepsin 14mg/m2 Days 1, 8 and 15 (4): Volasertib 150mg/m2 Days 1 \& 8; Romidepsin 14mg/m2 Days 1, 8 and 15 Each cycle is 28 days Each drug is given intravenously

Conditions

• PTCL
• CTCL

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-05-02
• Last updated: 2016-12-01