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    Summary
    EudraCT Number:2020-000825-18
    Sponsor's Protocol Code Number:CSET2020/3047
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-000825-18
    A.3Full title of the trial
    An open-label, multicentric, phase Ib/II study to assess the safety and efficacy of AsiDNATM, a DNA repair inhibitor, administered intravenously in addition to Niraparib in patients with relapsed platinum sensitive ovarian cancer already treated with Niraparib since at least 6 months (RevoCAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy study to evaluate AsiDNA in addition with Niraparib for treatment of relapsed platinum sensitive ovarian cancer already treated with Niraparib since at least 6 months
    A.3.2Name or abbreviated title of the trial where available
    RevoCAN (Resistance reversion of Ovarian Cancer with AsiDNA and Niraparib)
    A.4.1Sponsor's protocol code numberCSET2020/3047
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGustave Roussy
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOnxeo S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGustave Roussy
    B.5.2Functional name of contact pointThibault Motreff
    B.5.3 Address:
    B.5.3.1Street Address114 rue Edouard Vaillant
    B.5.3.2Town/ cityVillejuif
    B.5.3.3Post code94805
    B.5.3.4CountryFrance
    B.5.6E-mailThibaud.MOTREFF@gustaveroussy.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AsiDNA
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETIDALIGIDE
    D.3.9.3Other descriptive nameASIDNA
    D.3.9.4EV Substance CodeSUB190792
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed platinum sensitive ovarian cancer
    E.1.1.1Medical condition in easily understood language
    Relapsed platinum sensitive ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: to assess safety of iv infusions of AsiDNA in addition to Niraparib during the first cycle
    Part B: to assess preliminary efficacy on CA-125 of AsiDNA in addition to Niraparib
    E.2.2Secondary objectives of the trial
    Part A and B
    - Overall safety of iv infusions of AsiDNA in addition to Niraparib
    - CA 125 (Part A)
    - Progression-Free Survival
    - Overall Survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
    2. Female aged ≥ 18 years (no upper limit of age) at the time of consent signature.
    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    4. Life expectancy of at least 3 months.
    5. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer regardless BRCA status.
    6. Availability of BRCA status;
    7. Patient has received at least 2 previous courses of platinum-containing therapy and has a disease that was considered platinum sensitive that means in response (complete or partial) to the last platinum course leading to the administration of Niraparib.
    8. The patient has received Niraparib in maintenance for at least 6 months and who has only an increase of CA125 at least twice the upper limit of normal within 2 weeks prior to starting treatment without any progression according to RECIST criteria
    9. Patient should be treated within 2 weeks after CT scan without any progression according to RECIST criteria
    10. Patient with adequate biological parameters at baseline defined as:
    • absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L,
    • hemoglobin (Hb) level ≥ 9g/dL,
    • platelet count ≥ 100 x 10e9/L,
    • total bilirubin level ≤ 1.5 Upper Limit Normal (ULN),
    • aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN,
    • calculated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73m2 (per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula),
    • INR ≤ 1.2 (except if patient treated with anti-vitamine K); anticoagulation with anti-vitamin K and Low Molecular Weight Heparin [LMWH] is allowed.
    11. Patient of childbearing potential must agree to use adequate contraception prior to study entry, during the study and for 3 months after the study participation.
    12. Patient of childbearing potential must have a serum negative pregnancy test within 4 days prior to first administration. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
    13. Patient must be affiliated to a social security system or an equivalent system.
    E.4Principal exclusion criteria
    1. Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
    2. Patient treated concomitantly with bevacizumab
    3. Patient previously treated with PARPi as first line maintenance
    4. Other Malignancy within the last 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix, and in situ breast cancer
    5. Patient with central nervous system (CNS) metastases;
    6. Other tumor location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture).
    7. Patient with uncontrolled disease-related metabolic disorder (e.g., hypercalcemia, SIADH) or uncontrolled diabetes.
    8. Quantitative total urine protein > 1.0 g/24 hour) at baseline
    9. Patient with uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or IV, uncontrolled hypertension, unstable heart disease (e.g., coronary artery disease with unstable angina or myocardial infarction within 6 months before study treatment administration).
    10. Patient with significant ECG abnormalities defined as any cardiac dysrhythmia (> grade 2) (i.e., significant ventricular arrhythmia as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrio-ventricular block 2 and 3, sino-atrial block) or baseline QT/QTc interval >480 milliseconds (ms).
    11. Patient with significant chronic liver disease (e.g., significant fibrosis, known cirrhosis) or active HBV or HCV infection; if AgHbs positive, an effective antiviral treatment to prevent hepatitis B reactivation is recommended.
    12. Patient with HIV infection or an active infection requiring specific anti-infective therapy are not eligible until all signs of infection have resolved, and this within 2 weeks prior to the first study treatment administration.
    13. Patient whose medical, psychological including alcohol or drug abuse, or surgical conditions are unstable and may affect the study completion and/or compliance and/or the ability to give informed consent.
    14. Participation in another clinical trial with any investigational drug within 28 days prior to first study drug administration.
    15. Vulnerable adult patients benefiting from a specific legal protection status.
    16. Patient who has received mouse antibodies (unless the assay used has been shown not to be influenced by HAMA4,5) or if there has been medical and/or surgical interference with their peritoneum or pleura during previous 28 days.
    17. Patient pregnant or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Overall Safety
    Part B: Preliminary efficacy on CA-125
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: First cycle of treatment (from D1 to D21)
    Part B: After 2 cycles of treatment (from D1 to D42)
    E.5.2Secondary end point(s)
    Part A and B:
    - Overall Safety of iv infusions of AsiDNATM in addition to Niraparib
    - CA 125 (for Part A)
    - Progression-Free Survival
    - Overall Survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety and efficacy study (Phase 1b/2)
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 26
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
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