NCT02028117

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2019

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

5.5 years

First QC Date

January 3, 2014

Last Update Submit

May 11, 2021

Conditions

Recurrent Platinum Resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Phase I - maximum tolerated dose

    The maximally-tolerated dose (MTD) and/or the dose of enadenotucirev recommended for further studies of enadenotucirev when administered as monotherapy by IP injection or as combination therapy by IV infusion with weekly paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.

    Up to day 50 (post first dose)

Study Arms (1)

Enadenotucirev

EXPERIMENTAL
Biological: Enadenotucirev

Interventions

EnadenotucirevBIOLOGICAL

Oncolytic Virus

Enadenotucirev

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to provide written informed consent and to comply with the study protocol
  • Age ≥ 18 years
  • Histologically confirmed non-resectable epithelial ovarian, fallopian tube or primary peritoneal cancer
  • Phase Ia and Phase Ib (first 3 patients):
  • Confirmed relapsed within the platinum-resistant time frame.
  • Platinum-resistance is defined as progression within 6 months of receiving prior platinum-containing chemotherapy, with progression identified either by CT scanning (RECIST v1.1) or symptomatic CA-125 progression (GCIG CA-125 criteria)
  • The treatment immediately prior to study entry need not be platinum-based OR Absence of other available treatment option
  • Phase Ib (after first 3 patients) and Dose Expansion Phase:
  • Confirmed relapsed within the platinum-resistant time frame
  • Platinum-resistance is defined as progression within 6 months of receiving prior platinum-containing chemotherapy, with progression identified either by CT scanning (RECIST v1.1) or symptomatic CA-125 progression (GCIG CA-125 criteria)
  • The treatment immediately prior to study entry need not be platinum-based
  • Phase Ia and Phase Ib (first 3 patients):
  • Evaluable disease (by RECIST v1.1).
  • Phase Ib (after first 3 patients) and Dose Expansion Phase:
  • Measurable disease (by RECIST v1.1)
  • +19 more criteria

You may not qualify if:

  • Patients who meet any of the following criteria are not eligible for enrolment:
  • Tumours of malignant mixed mesodermal (MMMT) or mucinous subtypes, or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours)
  • \[Criterion 2 has been removed in the current version of the protocol\]
  • Symptomatic sub-acute bowel obstruction, characterised by e.g. regular bloating, nausea, vomiting, constipation or diarrhoea
  • Pregnant or lactating (nursing) women
  • Known and/or a history or evidence of significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus \[HIV\]/acquired immunodeficiency syndrome \[AIDS\]) and/or medication (e.g. systemic corticosteroids at doses higher than dexamethasone 20 mg \[or other corticosteroid equivalent to dexamethasone dose\] for 14 days or prolonged administration \[\>14 days\] of dexamethasone at doses higher than 10 mg but 20 mg \[or other corticosteroid equivalent to dexamethasone dose\] or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 14 days)
  • Complete splenectomy
  • Prior allogeneic or autologous bone marrow or organ transplantation
  • Active infections requiring antibiotics, physician monitoring, or recurrent fevers \>38.0 degrees centigrade associated with a clinical diagnosis of active infection
  • Active viral disease, positive serology for HIV, hepatitis B or hepatitis C
  • Use of the following anti-viral agents:
  • Ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1
  • or pegylated interferon (PEG-IFN) (within 14 days prior to day 1)
  • Administration of an investigational drug within 28 days
  • Concurrent administration of any cancer therapy other than planned study treatment
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Clara Campal Comprehensive Cancer Center Hospital

Madrid, Spain

Location

MD Anderson Cancer Center

Madrid, Spain

Location

START MADRID-FJD, Hospital Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

The Royal Surrey County Hospital

Guildford, Surrey, GU2 7WG, United Kingdom

Location

Beatson Institute

Glasgow, G61 1BD, United Kingdom

Location

The Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Related Publications (2)

  • Khalil DN, Prieto Gonzalez-Albo I, Rosen L, Lillie T, Stacey A, Parfitt L, Soff GA. A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies. Invest New Drugs. 2023 Apr;41(2):317-323. doi: 10.1007/s10637-023-01345-8. Epub 2023 Mar 10.

    PMID: 36897458DERIVED

  • Moreno V, Barretina-Ginesta MP, Garcia-Donas J, Jayson GC, Roxburgh P, Vazquez RM, Michael A, Anton-Torres A, Brown R, Krige D, Champion B, McNeish I. Safety and efficacy of the tumor-selective adenovirus enadenotucirev with or without paclitaxel in platinum-resistant ovarian cancer: a phase 1 clinical trial. J Immunother Cancer. 2021 Dec;9(12):e003645. doi: 10.1136/jitc-2021-003645.

    PMID: 34893524DERIVED

Related Links

MeSH Terms

Interventions

enadenotucirev

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 6, 2014

Study Start

June 1, 2014

Primary Completion

November 19, 2019

Study Completion

November 19, 2019

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations

GB(3)ES(5)