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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-000518-39
    Sponsor's Protocol Code Number:CO-338-014
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-17
    Trial results View 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 number2013-000518-39
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of Maintenance Rucaparib in Relapsed High-grade Ovarian Cancer
    A.3.2Name or abbreviated title of the trial where available
    ARIEL 3
    A.4.1Sponsor's protocol code numberCO-338-014
    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 SponsorClovis Oncology, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportClovis Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClovis Oncology UK Ltd
    B.5.2Functional name of contact pointVP Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressSheraton House, Castle Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB3 0AX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223370037
    B.5.6E-maillrolfe@clovisoncology.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1049
    D.3 Description of the IMP
    D.3.1Product nameRucaparib
    D.3.2Product code CO-338
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRucaparib camsylate
    D.3.9.1CAS number 283173-50-2
    D.3.9.3Other descriptive nameRUCAPARIB
    D.3.9.4EV Substance CodeSUB74859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
    E.1.1.1Medical condition in easily understood language
    Ovarian, Primary Peritoneal or Fallopian Tube Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061269
    E.1.2Term Malignant peritoneal neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST), as assessed by the investigator, in molecularly-defined homologous recombination deficiency (HRD) subgroups
    E.2.2Secondary objectives of the trial
    To evaluate PFS by RECIST, as assessed by independent radiology review (IRR), in molecularly-defined HRD subgroups
    To evaluate patient-reported outcome (PRO) of disease-related symptoms utilizing the disease-related symptoms – physical (DRS–P) subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index 18 (FOSI-18)
    To evaluate PRO utilizing the complete FOSI-18
    To evaluate survival benefit
    To evaluate safety
    To determine the population pharmacokinetics (PK) of rucaparib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation
    2. Be ≥ to 18 years of age at the time the informed consent form is signed
    3. Have a histologically confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
    -For mixed histology, >50% of the primary tumor must be confirmed to be high-grade serous or endometrioid
    4. Received prior platinum based therapy and have platinum sensitive disease (i.e. documented radiologic disease progression >6 months following the last dose of the penultimate platinum administered)
    -Received ≥2 prior platinum-based treatment regimens, including platinum-based regimen that must have been administered immediately prior to maintenance therapy in this trial. In addition, up to 1 non-platinum is permitted.
    -There is no upper limit on the number of prior platinum-based regimens that may have been received, but the patient must have been sensitive to the penultimate platinum-based regimen administered.
    -If both neoadjuvant and adjuvant treatment were administered pre/post any debulking surgery, this will be considered 1 treatment regimen
    -Prior continuous (e.g. bevacizumab) or switch maintenance therapy following any prior treatment regimen is permitted
    5. Achieved best response of either complete response (CR) (defined as complete radiologic response by RECIST) or partial response (PR) (defined as partial response by RECIST and/or a Gynecological Cancer Intergroup Guidelines (GCIG) CA-125 response) to the most recent platinum-based regimen administered (4 cycles minimum) and maintained response through completion of chemotherapy
    -All responses require that CA-125 be < upper limit of normal (ULN). Response must have been maintained to permit entry into the study.
    -All disease assessments performed prior to and during this chemotherapy regimen must be adequately documented in the patient’s medical record
    6. Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue (1 x 4 µm section for hematoxylin and eosin [H&E] stain and approximately 8 to 12 x 10 µm sections, or equivalent) available for planned analyses.
    -The most recently collected tumor tissue should be provided, if available
    -Submission of a tumor block is preferred; if sections are provided, these must all be from the same tumor sample.
    -Sample must be received at the central laboratory at least 3 weeks prior to planned start of treatment in order to enable stratification for randomization
    7. Have CA-125 measurement <ULN
    8. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    9. Have adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of study drug:
    a. Bone Marrow Function
    -Absolute neutrophil count (ANC) ≥1.5 × 109/L
    -Platelets >100 × 109/L
    -Hemoglobin ≥9 g/dL
    b. Hepatic Function
    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN; if liver metastases, then ≤5 × ULN
    -Bilirubin ≤1.5 × ULN
    c. Renal Function
    -Serum creatinine ≤1.5 × ULN or estimated glomerular filtration rate (GFR) ≥45 mL/min using the Cockcroft Gault formula
    E.4Principal exclusion criteria
    1. History of a prior malignancy except:
    a. Curatively treated non-melanoma skin cancer
    b. Breast cancer treated curatively >3 years ago, or other solid tumor treated curatively >5 years ago, without evidence of recurrence
    c. Synchronous endometrioid endometrial cancer (Stage 1A G1/G2)
    2. Prior treatment with any poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, including oral or intravenous rucaparib. Patients who previously received iniparib are eligible.
    3. Required drainage of ascites during the final 2 cycles of the last platinum-based regimen and/or during the period between the last dose of chemotherapy of that regimen and randomization to maintenance treatment in this study
    4. Symptomatic and/or untreated central nervous system (CNS) metastases. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks.
    5. Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption of study drug
    6. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C.
    7. Pregnant or breast feeding. Women of childbearing potential must have a negative serum pregnancy test <3 days prior to first dose of study drug
    8. Received treatment with chemotherapy, radiation, hormones, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤14 days prior to first dose of study drug and/or ongoing adverse effects from such treatment > National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) (NCI CTCAE) Grade 1
    9. Received administration of strong CYP1A2 or CYP3A4 inhibitors ≤7 days prior to first dose of study drug or have on-going requirements for these medications (Appendix F)
    10. Non-study related minor surgical procedure ≤5 days, or major surgical procedure ≤21 days, prior to first dose of study drug; in all cases, the patient must be sufficiently recovered and stable before treatment administration
    11. Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for the study

    Pregnancy is an exclusion criterion and women of childbearing potential must not be considering getting pregnant during the study.

    Patients of reproductive potential must practice an effective method of contraception during treatment and for 6 months following the last study drug dose.

    No waivers of these inclusion or exclusion criteria will be granted by the investigator and the sponsor or its designee for any patient enrolled into the study.
    E.5 End points
    E.5.1Primary end point(s)
    Disease progression according to RECIST Version 1.1 (v1.1), as assessed by the investigator, or death from any cause (invPFS), in molecularly defined subgroups
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessment/tumor scans at the end of every 3rd cycle of treatment (within 7 days prior to the start of the next cycle)
    E.5.2Secondary end point(s)
    1. Disease progression according to RECIST v1.1, as assessed by independent radiology review(IRR), or death from any cause (irrPFS), in molecularly defined subgroups
    2. Time to a 4-point decrease in the disease-related symptoms – physical (DSR-P subscale) of the FACT-Ovarian Symptom Index 18 (FOSI-18)
    3. Time to an 8-point decrease in the total score of the FOSI-18
    4. Overall Survival (OS)
    5. Incidence of AEs, clinical laboratory abnormalities, and dose modifications
    6. Individual model parameter estimates of rucaparib and covariates identification
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Disease assessment/tumor scans at the end of every 3rd cycle of treatment (within 7 days prior to the start of the next cycle)
    2. The FOSI-18 and EQ-5D instruments must be completed prior to other scheduled study procedures and dosing (if applicable) at Screening, on Day 1 of each treatment cycle, at treatment discontinuation, and at the 28-day post-treatment discontinuation follow-up visit for all patients
    3. As point 2.
    4. Every 12 weeks until death, loss to follow-up, withdrawal of consent from study, or closure of the study.
    5. AEs that occur after first dose through to 28 days after last dose of study drug will be recorded
    6. Day 15 of Cycle 1, on Day 1 of Cycle 2, on Day 15 of Cycle 2, and on Day 1 of Cycle 4 and Cycle 7.
    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 Yes
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    France
    Germany
    Israel
    Italy
    New Zealand
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The study will end after 70% of the patients in the tBRCA subgroup have an observed event of investigator-determined disease progression or death. If the minimum number of tBRCA patients are enrolled, then the study will end following the 126th event of investigator-determined disease progression or death. Similarly, if the maximum number of tBRCA patients are enrolled, then the study will end following the 140th event of investigator-determined disease progression or death.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 405
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 264
    F.4.2.2In the whole clinical trial 540
    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)
    Upon formal closure of the study, individual patients who are continuing to benefit from treatment with rucaparib at the time of study closure, and who do not meet any of the criteria for withdrawal, will have the option of entering an extension protocol in which they can continue to receive rucaparib. Otherwise, after the end of the study, patients will receive subsequent anticancer therapy at the investigator's discretion.
    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 Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-07
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