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    Summary
    EudraCT Number:2016-000816-14
    Sponsor's Protocol Code Number:CO-338-043
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-000816-14
    A.3Full title of the trial
    Phase 3 Multicenter, Randomized Study of Rucaparib versus Chemotherapy in Patients with Relapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
    Estudio de fase III, multicéntrico y aleatorizado para evaluar la eficacia de rucaparib frente a quimioterapia en pacientes con cáncer ovárico epitelial recidivante de alto grado con mutación de BRCA, cáncer peritoneal primario o de trompas de falopio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test efficacy of Rucaparib in patients with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
    Estudio para evaluar la eficacia de rucaparib en pacientes con cancer ovarico epithelial, de trompas de falopio o cancer peritoneal primario.
    A.3.2Name or abbreviated title of the trial where available
    ARIEL4
    ARIEL4
    A.4.1Sponsor's protocol code numberCO-338-043
    A.5.4Other Identifiers
    Name:IND numberNumber:106289
    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 pointChief Medical Officer
    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+4401223 370037
    B.5.6E-mailinfo@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.3.4Pharmaceutical 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
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    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 number200
    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.IMP: 2
    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.3.1Product nameRucaparib
    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
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    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 number250
    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.IMP: 3
    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.3.4Pharmaceutical 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
    D.3.9.1CAS number 283173-50-2
    D.3.9.2Current sponsor codeCO-338
    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 number300
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.1Product nameCarboplatin
    D.3.4Pharmaceutical form 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 INNCarboplatin
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.1Product nameCisplatin
    D.3.4Pharmaceutical form 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 INNCISPLATIN
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.1Product namePaclitaxel
    D.3.4Pharmaceutical form 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    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.IMP: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    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.3.1Product nameGemcitabine
    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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    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, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
    Recaida, mutacion-BRCA, ovarico epithelial alto grado, trompas de Falopioo cancer peritoneal pimario.
    E.1.1.1Medical condition in easily understood language
    Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
    ovario, trompas de Falopio, o cancer peritoneal primario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10038977
    E.1.2Term Retroperitoneal 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 19.0
    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 19.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine investigator-assessed progression-free survival (invPFS) by RECIST Version 1.1 for rucaparib versus chemotherapy.
    Determinar la supervivencia sin progresión evaluada por el investigador (invPFS) conforme a la versión 1.1 de RECIST para el rucaparib frente a quimioterapia.
    E.2.2Secondary objectives of the trial
    -To compare efficacy of rucaparib versus chemotherapy as measured by overall survival (OS)
    -To compare efficacy of rucaparib versus chemotherapy as measured by ORR using RECIST Version 1.1 by investigator assessment
    -To compare efficacy of rucaparib versus chemotherapy as measured by DOR by investigator assessment
    -To compare efficacy of rucaparib versus chemotherapy as measured by ORR using RECIST Version 1.1 by investigator assessment and Gynecologic Cancer InterGroup (GCIG) CA-125 response criteria
    -To evaluate patient-reported outcome (PRO) for rucaparib versus chemotherapy as assessed by the:
    -European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
    -EORTC ovarian cancer module QLQ-OV28
    -To evaluate the safety and tolerability of rucaparib versus chemotherapy
    - Comparar la eficacia de rucaparib frente a la quimioterapia en términos de supervivencia total
    - Comparar la eficacia de rucaparib frente a la quimioterapia en términos del IRG empleando la versión 1.1 de RECIST y mediante la evaluación del investigador
    - Comparar la eficacia de rucaparib frente a la quimioterapia en términos de DdR conforme a la evaluación del investigador
    - Comparar la eficacia de rucaparib frente a la quimioterapia en términos de DdR empleando la versión 1.1 de RECIST, conforme a la eva. del investigador y los criterios de respuesta de CA-125 del Gynecologic Cancer InterGroup (GCIG)
    - Eva. los resultados comunicados por la paciente (RCP) para rucaparib frente a la quimioterapia, conforme a la evaluación del:
    •Cuestionario sobre calidad de vida (EORTC QLQ) C30 de la Asociación europea para la inv. y tto. del cancer
    •Módulo QLQ OV28 para el cáncer ovárico de la EORCT
    - Eva. la seguridad terapéutica y la tolerabilidad del rucaparib frente a la quimioterapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-specific evaluation
    2. Be ≥ 18 years of age at the time the informed consent form is signed
    3. Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
    a. If mixed histology, > 50% of the primary tumor must be confirmed to be high-grade serous or endometrioid upon review by local pathology
    b. Patients with a histology of other than serous or endometrioid are also eligible if they are known to harbor a deleterious germline or somatic BRCA1/2 mutation
    4. Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
    a. Had documented treatment-free interval of ≥ 6 months following the first chemotherapy regimen received
    b. Hormonal agents (eg, tamoxifen, letrozole, etc), anti-angiogenic agents (eg, bevacizumab, pazopanib, cediranib, etc), and other non-chemotherapy agents will not be counted as a chemotherapy regimen for the purpose of determining patient eligibility
    c. Agents administered in the maintenance setting will not be counted as a separate regimen
    5. Have a deleterious BRCA1/2 mutation as confirmed by the central laboratory.
    Note: patients known to harbor a deleterious germline or somatic BRCA1/2 mutation based on local assessment may be enrolled without central tissue analysis provided there is confirmation that tumor tissue is available to be provided to the central laboratory.
    a. Sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue must available for planned analyses; cytospin blocks from ascites are not acceptable i. The most recently obtained tumor tissue that is of adequate quality (at least 20% tumor content with a minimum of 80% nucleated cellular content) should be submitted.
    b. In the event archival tumor tissue is not available a screening biopsy sample may be collected and provided to the central laboratory
    6. Have evaluable disease: ie at least 1 target or non-target lesion that can be assessed per RECIST Version 1.1 (Appendix 1)
    7. Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to randomization:
    a. Bone Marrow Function
    i. Absolute neutrophil count (ANC) ≥ 2.0 × 109/L
    ii. Platelets > 100 × 109/L
    iii. Hemoglobin > 10 g/dL
    b. Hepatic Function
    i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
    ii. Bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert’s syndrome
    iii. Serum albumin ≥ 30 g/L (3.0 g/dL)
    c. Renal Function
    i. Serum creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft-Gault formula
    8. Women of childbearing potential must have a negative serum pregnancy test ≤ 3 days prior to administration of the first dose of study drug
    9. Have an ECOG performance status of 0 or 1 (Appendix 2)
    1.Haber firmado un formulario de consentimiento informado autorizado por una Junta de Revisión Institucional (JRI) o Comité de Ética de Investigación Clínica (CEIC) antes de iniciar cualquier evaluación específica del studio
    2.Tener ³ 18 años de edad en el momento de firmar el formulario de consentimiento informado
    3.Tener un diagnóstico confirmado histológicamente de cáncer de tipo ovárico epitelial endometrioide seroso de alto grado o de grado 3 o 2, de trompas de falopio o peritoneal primario
    a.Si la histología es mixta, se deberá confirmar que > 50 % del tumor principal es seroso o endometrioide de alto grado mediante revisión por el laboratorio de patología local
    b.Las pacientes con una histología que no sea de tipo seroso o endometrioide también serán aptas para participar en el estudio, si se confirma que presentan una mutación deletérea de línea germinal o somática de BRCA1/2
    4.Haber recibido ≥ 2 tratamientos con quimioterapia anteriores y presentar una evolución o recaída de la enfermedad confirmada por evaluación radiológica
    a.Haber pasado un intervalo sin tratamiento documentado de ≥ 6 meses tras el primer régimen de quimioterapia recibido
    b.Los agentes hormonales (p. ej., tamoxifeno, letrozol, etc.), los agentes antiangiogénicos (p. ej., bevacizumab, pazopanib, cediranib, etc.) y otros agentes que no sean propios de la quimioterapia no se considerarán como regímenes de quimioterapia a la hora de determinar la idoneidad de las pacientes
    c.Los agentes administrados en una situación de mantenimiento no se considerarán como un régimen aparte
    5.Presentar una mutación deletérea de BRCA1/2 confirmada por el laboratorio central. Nota: Las pacientes que, según una evaluación local, presenten una mutación deletérea de línea germinal o somática de BRCA1/2 podrán inscribirse sin el análisis de tejido del laboratorio central, siempre que se confirme que se puede proporcionar tejido tumoral al laboratorio central
    a.Deberá haber suficiente tejido tumoral de archivo, fijado con formol e incluido en parafina, disponible para los análisis planificados; los bloques de cytospin procedentes de ascitis no son aceptables.
    i. Se deberá enviar el tejido tumoral más reciente que presente la calidad adecuada (al menos 20 % de contenido tumoral con un mínimo del 80 % de contenido celular nucleado)
    b.En el caso de que no se disponga de tejido tumoral de archivo, se obtendrá una muestra de una biopsia de selección que se enviará al laboratorio central.
    6.Tener una enfermedad evaluable, es decir, con al menos 1 lesión objetivo o no objetivo que se pueda evaluar conforme a los criterios RECIST versión 1.1.
    7.Presentar una actividad de los órganos adecuada, confirmada mediante las valoraciones analíticas siguientes obtenidas dentro de los 14 días anteriores a la aleatorización:
    a.Actividad de la médula ósea
    i.Recuento absoluto de neutrófilos (RAN) ³ 2,0 × 109/l
    ii.Plaquetas > 100 × 109/l
    iii.Hemoglobina > 10 g/dl
    b.Actividad hepatica
    i.Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) £ 3 × límite superior de la normalidad (LSN); £ 5 × LSN en caso de metástasis hepática
    ii.Bilirrubina £ 1,5 × LSN; < 2 × LSN si la hiperbilirrubinemia se debe al síndrome de Gilbert
    iii.Albúmina en suero ≥ 30 g/l (3,0 g/dl)
    c.Actividad renal
    i.Creatinina en suero ≤ 1,5 x LSN o tasa de filtración glomerular estimada ≥ 45 ml/min mediante la fórmula de Cockcroft-Gault
    8.Las pacientes con capacidad para procrear deberán disponer de una prueba de embarazo en suero con resultado negativo en un plazo de ≤ 3 días previo a la primera dosis de fármaco del estudio.
    9.Tener un estado funcional del Grupo Oncológico Cooperativo de la Costa Este (ECOG) de 0 o 1
    E.4Principal exclusion criteria
    1. Active second malignancy, ie, patient known to have potentially fatal cancer present for which she may be (but not necessarily) currently receiving treatment
    a. Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed > 6 months prior and/ or bone marrow transplant > 2 years prior to first dose of study drug
    2. Prior treatment with any PARP inhibitor, including rucaparib.
    3. Prior treatment with single-agent paclitaxel for platinum-resistant disease.
    4. Prior known hypersensitivity to paclitaxel (for patients with progression-free interval of < 12 months after last platinum-based regimen) or prior known hypersensitivity to platinum (for patients with progression-free interval of ≥ 12 months after last platinum-based regimen.
    5. Platinum refractory disease: disease progressed by radiologic assessment during or within 4 weeks after completing treatment with most recent platinum-based therapy
    6. 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 after completion of therapy
    7. Pre-existing duodenal stent and/ or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
    8. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C
    9. Women who are pregnant or breast feeding
    10. Received treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior to first dose of study drug
    11. Ongoing toxicity ≥ Grade 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (ongoing Grade 2 non-hematologic toxicity, with the exception of peripheral neuropathy, may be permitted with prior advanced approval from sponsor).
    12. 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
    13. Requires regular blood transfusions, granulocyte colony-stimulating factor, or platelet transfusions
    14. Drainage of ascitic fluid 2 or more times in the 4 weeks prior to the first dose of study drug, uncontrolled pleural effusion, or permanent drain in place (eg, PleurX®) for ascites or pleural effusion
    15. Hospitalization for bowel obstruction within 3 months prior to randomization
    16. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study
    1.Una neoplasia maligna secundaria activa, es decir, se sabe que la paciente padece un cáncer potencialmente mortal para el que puede (aunque no necesariamente) estar siendo tratado en la actualidad.
    a.Las pacientes con antecedentes de neoplasia maligna que hayan sido completamente tratados y actualmente no presenten indicios de dicha neoplasia podrán inscribirse en el ensayo siempre y cuando todo el proceso quimioterapéutico haya finalizado > 6 meses antes o hayan recibido cualquier transplante de médula > 2 años antes de la primera dosis de fármaco del estudio.
    2.Tratamiento previo con cualquier inhibidor de PARP, incluido el rucaparib.
    3.Tratamiento previo con paclitaxel de agente único en caso de enfermedad resistente al platino.
    4.Hipersensibilidad previa conocida al paclitaxel (en el caso de las pacientes con un intervalo sin progresión de < 12 meses tras el último régimen con platino) o hipersensibilidad previa conocida al platino (en el caso de las pacientes con un intervalo sin progresión de ≥ 12 meses tras el último régimen con platino).
    5.Enfermedad resistente al platino: evolución de la enfermedad según evaluación radiológica durante o dentro de 4 semanas después de finalizar el tratamiento con la terapia más reciente basada en platino.
    6.Metástasis del sistema nervioso central (SNC) sintomáticas y/o sin tratar. Las pacientes con metástasis del SNC tratadas previamente y asintomáticas serán aptas siempre que hayan estado clínicamente estables durante al menos 4 semanas tras completar la terapia.
    7.Prótesis duodenal preexistente o trastornos o defectos digestivos que, en opinión del Investigador, pudieran interferir con la absorción del rucaparib.
    8.Constancia de alguna enfermedad relacionada con el virus de la inmunodeficiencia humana (VIH) o el síndrome de inmunodeficiencia adquirida (SIDA), o antecedentes de hepatitis B o C crónica.
    9.Mujeres embarazadas o en periodo de lactancia.
    10.Haber recibido tratamiento con quimioterapia, radioterapia, tratamiento con anticuerpos o cualquier otra inmunoterapia, terapia génica, terapia con vacunas, inhibidores de la angiogénesis o con fármacos experimentales £ 14 días antes de la primera dosis de fármaco del estudio.
    11.Toxicidad ≥ grado 2 en curso conforme a los criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute (NCI CTCAE) (la toxicidad en curso de grado 2 no hematológica, excepto la neuropatía periférica, se podrá permitir previa autorización del promotor).
    12.Intervención quirúrgica menor no relacionada con el estudio £ 5 días antes, o bien cirugía mayor £ 21 días antes de la primera dosis de fármaco del estudio; en todos los casos, la paciente deberá estar suficientemente recuperada y estable antes de administrar el tratamiento.
    13.Pacientes que necesiten transfusiones de sangre, factor estimulante de colonias de granulocitos o transfusiones de plaquetas con regularidad.
    14.Pacientes que necesiten transfusiones de sangre, factor estimulante de colonias de granulocitos o transfusiones de plaquetas con regularidad.
    15.Hospitalización por obstrucción del intestino en los 3 meses anteriores a la aleatorización.
    16.Presencia de cualquier otra afección que pudiera aumentar el riesgo asociado con la participación en el estudio o que pudiera interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, hiciera que la paciente no fuera apta para inscribirse en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Disease progression according to RECIST Version 1.1 as assessed by the Investigator, or death from any cause
    Progresion de la enfermedad evaluada por el investigador conforme a la version 1.1 de RECIST, o muerte por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first event of disease progression, assessment will be carried out every 8 weeks
    El primer acontecimiento de progression de la enfermedad, la evaluacion se hara cada 8 semanas.
    E.5.2Secondary end point(s)
    1).To compare efficacy of rucaparib versus chemotherapy as measured by overall survival (OS)
    2).To compare efficacy of rucaparib versus chemotherapy as measured by ORR using RECIST Version 1.1 by investigator assessment
    3).To compare efficacy of rucaparib versus chemotherapy as measured by DOR by investigator assessment
    4).To compare efficacy of rucaparib versus chemotherapy as measured by ORR using RECIST Version 1.1 by investigator assessment and Gynecologic Cancer InterGroup (GCIG) cancer antigen 125 (CA-125) response criteria
    5).To evaluate patient-reported outcome (PRO) for rucaparib versus chemotherapy as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and ovarian cancer module QLQ-OV28
    6).To evaluate the safety and tolerability of rucaparib versus chemotherapy.
    1. Comparar la eficacia de rucaparib frente a quimioterapia en términos de supervivencia total (ST).
    2. Comparar la eficacia de rucaparib frente a la quimioterapia en términos del IRG empleando la versión 1.1 de RECIST y mediante la evaluación del investigador.
    3. Comparar la eficacia de rucaparib frente a la quimioterapia en términos de DdR conforme a la evaluación del investigador.
    4. Comparar la eficacia de rucaparib frente a la quimioterapia en términos de DdR empleando la versión 1.1 de RECIST, conforme a la evaluación del investigador y los criterios de respuesta de CA-125 del Gynecologic Cancer InterGroup (GCIG).
    5. Evaluar los resultados comunicados por la paciente (RCP) para rucaparib frente a la quimioterapia, conforme a la evaluación del cuestionario sobre calidad de vida (EORTC QLQ) C30 de la Asociación europea para la investigación y tratamiento del cáncer y módulo QLQ OV28 para el cáncer ovárico de la EORCT
    6. Evaluar la seguridad terapéutica y la tolerabilidad del rucaparib frente a la quimioterapia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Patients will be followed for 28 days after last dose, long-term follow-up assessments every 12 weeks until death, withdrawal of consent or study closure
    2) RECIST at screening, at end of every 8 weeks relative to Cycle 1 Day 1 until radiologically confirmed disease progression by RECIST, as assessed by investigator, or death
    3) DOR will be summarized & analyzed using the same methodology described for primary endpoint
    4) At screening & end of every 8 weeks relative to Cycle 1 Day 1 after randomization.
    5) PRO’s will be completed by patients at screening, Day 1 of treatment, treatment discontinuation & 28-day safety follow-up
    6) Changes from baseline will be analyzed for each post-baseline visit & for final visit for each subscale & total score
    1.Se realizará un seguimiento de las pacientes para evaluar la seguridad y la eficacia durante los 28 días siguientes a la última dosis , habrá evaluaciones de seguimiento a largo plazo cada 12 semanas hasta que se produuzca muerte, retirada del consentimieto o cierre del studio.
    2.RECIST en la seleccion, al final de cada 8 semanas en relacion al Ciclo 1 dia 1 hasta confirmacion radiologica de progression por RECIST, conforme a la evaluacion del investigador o muerte
    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 No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Brazil
    Canada
    Czech Republic
    Hungary
    Israel
    Italy
    Poland
    Russian Federation
    Spain
    Ukraine
    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 trial will close when the required number of PFS events has been observed and sufficient follow-up for OS events has occurred.
    El Estudio se cerrará cuando el numero de PFS ha sido observado y un numero suficiente de Follo-up hayan ocurrido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 345
    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.
    Tras el cierre del studio, los pacientes que sigan beneficiandose del tratamiento con rucaparib en el momento de cierre del studio, y que no cumplan ninguno de los criterios de retirada, tendran la opcion de entrar en un protocol de extension en el cual podran continuar recibiendo rucaparib.
    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 Decision2016-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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