Trials / Completed
CompletedNCT02028117
Phase I / Dose Expansion Study of Enadenotucirev in Ovarian Cancer Patients
A Clinical Study Of Enadenotucirev: Dose Finding and Proof of Concept in Platinum-Resistant Epithelial Ovarian Cancer.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Akamis Bio · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Enadenotucirev | Oncolytic Virus |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2019-11-19
- Completion
- 2019-11-19
- First posted
- 2014-01-06
- Last updated
- 2021-05-13
Locations
8 sites across 2 countries: Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02028117. Inclusion in this directory is not an endorsement.