CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
Enadenotucirevbiological
Likely dose
Not stated in 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/NCT02028117
NCT02028117Phase 1Completed

A Clinical Study Of Enadenotucirev: Dose Finding and Proof of Concept in Platinum-Resistant Epithelial Ovarian Cancer.

Akamis Bio·interventional·Posted Jan 6, 2014·Updated May 13, 2021

In Brief

A Phase 1 clinical trial evaluating Enadenotucirev for Recurrent Platinum Resistant Ovarian Cancer. Completed, enrolled 38 participants across 8 sites in 2 countries.

Detailed Summary

This study is a Phase I / Dose Expansion open label clinical study in patients with platinum-resistant epithelial ovarian cancer. The Phase Ia part of the study will determine the dose of enadenotucirev to be recommended for further studies and will examine primarily the safety and tolerability but also the pharmacokinetics of administering enadenotucirev intraperitoneally. In Phase Ib, the safety and tolerability and the pharmacokinetics of administering enadenotucirev intravenously in combination with weekly paclitaxel will be determined. The Dose Expansion Phase will begin as an open label dose expansion of that regimen and aims to determine whether intravenous enadenotucirev in combination with weekly paclitaxel has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 6, 2014
Enrollment StartJun 1, 2014
Primary CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 12.5 years ago

Interventions

Enadenotucirevbiological

Oncolytic Virus