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Phase I / Dose Expansion Study of Enadenotucirev in Ovarian Cancer Patients

NCT02028117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-05-13

No results posted yet for this study

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

  • Recurrent Platinum Resistant Ovarian Cancer

Interventions

BIOLOGICAL

Enadenotucirev

Oncolytic Virus

Sponsors & Collaborators

  • Akamis Bio

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2019-11-19
Completion
2019-11-19

Countries

  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028117 on ClinicalTrials.gov