CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
Tinostamustine 60mg/m2 over 30min +6 moredrug
Likely dose
Tinostamustine 60mg/m2 over 30minfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03345485
NCT03345485Phase 2Completed
CompareCT.gov

A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of EDO-S101, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients With Advanced Solid Tumors. Sub-study to Characterize the Effects of Tinostamustine at a Dose of 60mg/m2 Administered During a 60 Minutes Infusion on Cardiac Repolarization, in Patients With Advanced Solid Tumors. Sub-study to Characterize the Effects of Tinostamustine at a Dose of 80mg/m2 Administered During a 80 Minutes Infusion on Cardiac Repolarization, in Patients With Advanced Solid Tumors.

Mundipharma Research Limited·interventional·Posted Nov 17, 2017·Updated Oct 21, 2024

In Brief

A Phase 2 clinical trial evaluating Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, and 5 other interventions for Small Cell Lung Cancer and 4 related conditions. Completed, enrolled 71 participants across 13 sites in 5 countries.

Detailed Summary

Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tinostamustine in subjects with advanced solid tumours. Subjects will be given Tinostamustine via intravenous infusion on Days 1 and 15 of a 4-week cycle, the dose and infusion time will vary depending on the phase of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer, Endometrial Cancer
CountriesCanada, Italy, Netherlands, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartNov 8, 2017
Primary CompletionJul 27, 2022
Study CompletionMar 29, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 8.6 years ago

Interventions

Tinostamustine 60mg/m2 over 30mindrug

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.

Tinostamustine 80mg/m2 over 30mindrug

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.

Tinostamustine 100mg/m2 over 30mindrug

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.

Tinostamustine 60mg/m2 over 60mindrug

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.

Tinostamustine 80mg/m2 over 60mindrug

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.

Tinostamustine 100mg/m2 over 60mindrug

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.

Tinostamustine 80mg/m2 over 80mindrug

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.