AzTrials
AzTrials

Recurrent Platinum Resistant Ovarian CancerPhase 1OCTAVENCT02028117

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

A Phase 1 study testing Enadenotucirev in people with Recurrent Platinum Resistant Ovarian Cancer, run by Akamis Bio at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Enadenotucirev
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
8 sitesin 2 countries
Study dates
Jun 2014to 19 Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 34Show fewer
  • 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)
  • Able to undergo IP injection, including all administration procedures e.g. placement of IP catheter, iatrogenic ascites and ascites drainage and comply with study procedures in the Investigator's opinion (only required for patients scheduled for IP administration)
  • Recovered to at least grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancy at time of first administration of enadenotucirev
  • ECOG Performance Status Score of 0 - 1
  • Non-impaired renal function
  • Creatinine ≤1.5 mg/dl and estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2 (or measured creatinine clearance ≥60 ml/min)
  • Urine dipstick for proteinuria at screening and baseline negative or trace. Patients may be included with results of 1+ if they have a spot urinary albumin:creatinine ratio (ACR) of either (i) ≤3 mg/mmol or (ii) >3 mg - <70 mg/mmol with a 24 hour urinary protein <0.2 g/24hours Adequate hepatic function
  • Serum bilirubin <1.5 x upper limit of normal (ULN)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/l
  • Platelets ≥100 x 109/l
  • Haemoglobin ≥90 g/l
  • Adequate coagulation tests: INR ≤1.5 x ULN;
  • [Criterion has been removed in the current version of the protocol]
  • For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment
  • For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year (e.g. hormonal implants, combined oral contraceptives, vasectomised partner), during the treatment period and for at least 3 months after the last dose of study drug
  • For selected patients in the Phase Ia and Dose Expansion Phase part of the study participating in the exploratory assessment of tumour samples:
  • Disease amenable to percutaneous image-guided biopsy.
  • Normal serum complement (C3/C4)

Who cannot join

  • 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)
Show all 24Show fewer
  • 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
  • Major surgery within 2 weeks prior to first dose of enadenotucirev
  • Phase Ib (after first 3 patients) and Dose Expansion Phase only: another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ or in situ stage 1 synchronous endometrial cancer)
  • Symptomatic central nervous system (CNS) metastasis
  • Inflammatory diseases of the bowel
  • Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease
  • Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug
  • Known allergy to treatment medication or its excipients
  • Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
  • Any history of renal disease or renal injury or autoimmune disease. Patients with active, known or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents; patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune disease only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enrol providing they comply with the other eligibility criteria relating to renal function)

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Spain5 sites

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • Clara Campal Comprehensive Cancer Center Hospital

    Madrid

  • MD Anderson Cancer Center

    Madrid

  • START MADRID-FJD, Hospital Fundación Jiménez Díaz

    Madrid

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United Kingdom3 sites

  • Beatson Institute

    Glasgow, G61 1BD

  • The Royal Surrey County Hospital

    Guildford, Surrey, GU2 7WG

  • The Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

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

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.

Being tested
Enadenotucirev

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnadenotucirevBiological

    Oncolytic Virus

Study groups in NCT02028117
Study groupRoleWhat they receive
EnadenotucirevExperimentalNot described
Receives: Biological: Enadenotucirev

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to day 50 (post first dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion19 Nov 2019
  4. Study completion19 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02028117
Sponsor's protocol ID
ColoAd1-2001
Acronym
OCTAVE
Status last verified
May 2021
First submitted
3 Jan 2014
Last updated
13 May 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36897458

  • 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.

    PubMed 34893524

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Enadenotucirev in people with Recurrent Platinum Resistant Ovarian Cancer, run by Akamis Bio at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I - maximum tolerated dose (time frame: Up to day 50 (post first dose)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02028117, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in