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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02028117
Recruitment Status : Recruiting
First Posted : January 6, 2014
Last Update Posted : March 21, 2018
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd

Brief Summary:
This study is a phase I/II open label clinical study in patients with platinum-resistant epithelial ovarian cancer. The Phase I 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. Once the dose of IP enadenotucirev to be used in combination with IV weekly paclitaxel has been determined, the phase II stage will begin as an open label dose expansion of that regimen. The phase II stage aims to determine whether intraperitoneal enadenotucirev has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian Cancer.

Condition or disease Intervention/treatment Phase
Recurrent Platinum Resistant Ovarian Cancer Biological: Enadenotucirev Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study Of Enadenotucirev: Dose Finding and Proof of Concept in Platinum-Resistant Epithelial Ovarian Cancer.
Actual Study Start Date : June 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Enadenotucirev Biological: Enadenotucirev
Oncolytic Virus

Primary Outcome Measures :
  1. Phase I - maximum tolerated dose [ Time Frame: Up to day 50 (post first 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 in patients with recurrent, platinum-resistant ovarian cancer.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Able and willing to provide written informed consent and to comply with the study protocol
  2. Age ≥ 18 years
  3. Histologically confirmed non-resectable ovarian, fallopian tube or primary peritoneal cancer
  4. 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 CA125 progression (GCIG CA-125 criteria).
    • The treatment immediately prior to study entry need not be platinum-based.
  5. Measurable disease (by RECIST v1.1).
  6. Able to undergo intraperitoneal injection and comply with study procedures in the Investigator's opinion
  7. Recovered to at least Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancy
  8. ECOG Performance Status Score of 0 - 1
  9. Adequate renal function

    • Creatinine ≤ 1.8 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ≥ 45 mL/min, or measured creatinine clearance ≥ 45 mL/min,
    • Absence of clinically significant haematuria on urinalysis: dipstick <2+
    • Absence of clinically significant proteinuria on urinalysis: dipstick < 2+.
  10. Adequate hepatic function

    • serum bilirubin <1.5 x ULN
    • AST and ALT ≤ 3 x ULN
  11. Adequate bone marrow function:

    • ANC ≥ 1.5 x 109/L,
    • platelets ≥ 100 x 109/L,
    • haemoglobin ≥ 90 g/L
  12. Adequate coagulation tests: INR ≤ 1.5 x ULN;
  13. Access to archival tumour samples
  14. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment;
  15. 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, vasectomized partner), during the treatment period and for at least 3 months after the last dose of study drug;
  16. For patients in the Phase II part of the study participating in the exploratory assessment of tumour samples:

    • Ovarian Disease amenable to percutaneous image-guided biopsy.

Exclusion Criteria:

  1. Tumours of malignant mixed mesodermal (MMMT) or mucinous subtypes, or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours).
  2. [Criterion 2 has been removed from the current version of the protocol].
  3. Unresolved bowel obstruction;
  4. Extensive intra-abdominal adhesions and / or tumoural involvement of the small bowel
  5. Pregnant or lactating (nursing) women;
  6. Known and/or a history or evidence of significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids at doses higher than dexamethasone 10 mg or equivalent, or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks);
  7. Splenectomy;
  8. Prior allogeneic or autologous bone marrow or organ transplantation;
  9. Active infections requiring antibiotics, physician monitoring, or recurrent fevers >38.0 degrees centigrade associated with a clinical diagnosis of active infection;
  10. Active viral disease, positive serology for HIV, hepatitis B or hepatitis C;
  11. Use of the following anti-viral agents:

    • ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1;
    • or PEG-IFN (within 14 days prior to day 1);
  12. Administration of an investigational drug within 28 days or within 5 half-lives of first dose of ColoAd1, whichever is longer.
  13. Administration of a systemic cancer therapy within 3 weeks of the first administration of Coload1
  14. Major surgery within 3 weeks or radiotherapy within 3 weeks prior to first dose of ColoAd1;
  15. Another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ);
  16. Known CNS metastasis;
  17. Inflammatory diseases of the bowel;
  18. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
  19. 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;
  20. Known allergy to treatment medication or its excipients;
  21. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02028117

Contact: PsiOxus Therapeutics

Clara Campal Comprehensive Cancer Center Hospital Recruiting
Madrid, Spain
Contact: Jesus Garcia-Donas, MD   
MD Anderson Cancer Center Recruiting
Madrid, Spain
Contact: Antonio González Martin, MD   
START MADRID-FJD, Hospital Fundación Jiménez Díaz Recruiting
Madrid, Spain
Contact: Victor Moreno, MD   
United Kingdom
The Royal Surrey County Hospital Recruiting
Guildford, Surrey, United Kingdom, GU2 7WG
Contact: Agnieszka Michael, MD   
Principal Investigator: Agnieszka Michael, MD         
Beatson Institute Recruiting
Glasgow, United Kingdom, G61 1BD
Contact: Iain McNeish, MD    0141 330 3968   
Principal Investigator: Iain McNeish, MD         
The Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Gordon Jayson, MD   
Principal Investigator: Gordon Jayson, MD         
Sponsors and Collaborators
PsiOxus Therapeutics Ltd

Responsible Party: PsiOxus Therapeutics Ltd Identifier: NCT02028117     History of Changes
Other Study ID Numbers: ColoAd1-2001
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type