Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

November 8, 2017

Primary Completion Date

July 27, 2022

Study Completion Date

March 29, 2023

Conditions
Small Cell Lung CancerSoft Tissue SarcomaTriple-negative Breast CancerOvarian CancerEndometrial Cancer
Interventions
DRUG

Tinostamustine 60mg/m2 over 30min

Tinostamustine as a single agent was administered at doses of 60mg/m2 by intravenous infusion over 30 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 80mg/m2 over 30min

Tinostamustine as a single agent was administered at doses of 80mg/m2 by intravenous infusion over 30 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 100mg/m2 over 30min

Tinostamustine as a single agent was administered at doses of 100mg/m2 by intravenous infusion over 30 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 60mg/m2 over 60min

Tinostamustine as a single agent was administered at doses of 60mg/m2 by intravenous infusion over 60 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 80mg/m2 over 60min

Tinostamustine as a single agent was administered at doses of 80mg/m2 by intravenous infusion over 60 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 100mg/m2 over 60min

Tinostamustine as a single agent was administered at doses of 100mg/m2 by intravenous infusion over 60 minutes on Days (D) 1 and 15 of each 28-day cycle.

DRUG

Tinostamustine 80mg/m2 over 80min

Tinostamustine as a single agent was administered at doses of 80mg/m2 by intravenous infusion over 80 minutes on Days (D) 1 and 15 of each 28-day cycle.

Trial Locations (13)

3015

Erasmus MC Kanker Instituut, Rotterdam

10016

New York University, New York

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

28046

Hospital Universitario La Paz, Madrid

48109

University of Michigan, Ann Arbor

75251

Mary Crowley Cancer Research, Dallas

90048

Cedars-Sinai Medical Center, Los Angeles

94304

Stanford University Medical Center, Palo Alto

L8V 1C3

Juravinski Cancer Centre, Hamilton

H4A 3J1

McGill University, Montreal

V5Z 1M9

BC Cancer-Vancouver, Vancouver

MI 20141

Istituto Europeo di Oncologia, Milan

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Mundipharma Research Limited

INDUSTRY

NCT03345485 - Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. | Biotech Hunter | Biotech Hunter