A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)

TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.

Study Overview

• Status: Completed
• Conditions: Metastatic Castration Resistant Prostate Cancer
• Intervention / Treatment: Drug: Rucaparib

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Miranda, Australia, 2228
    • Southside Cancer Care Centre
  • Orange, Australia, 2800
    • Orange Health Services
  • Subiaco, Australia, 6008
    • St John of God Hospital, Subiaco
  • Wagga Wagga, Australia, 2650
    • Riverina Cancer Care Centre
  • New South Wales
    • Saint Leonards, New South Wales, Australia, 2065
      • Northern Cancer Insitute, St. Leonards
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsula & Southeast Oncology
    • Geelong, Victoria, Australia, 3220
      • Barwon Health, University Hospital Geelong
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Gent, Belgium, B-9000
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Liège, Belgium, 4000
    • Equipe de Recherche Clinique, Département d'Oncologie/Hématologie
  • Roeselare, Belgium, B-8800
    • AZ Delta
• Canada
  • Toronto, Canada, M5G 2M9
    • Princess Margaret Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8V5C2
      • Juravinski Cancer Centre Hamilton Health Services
    • London, Ontario, Canada, N6A 4L6
      • London Health Science Center - Victoria Hospital
    • Ottawa, Ontario, Canada, K1H8L6
      • The Ottawa Hospital
• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Vejle, Denmark, 7100
    • Vejle Sygehus
• France
  • Caen, France, 14000
    • Centre Francois Baclesse
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc
  • Le Mans, France, 72000
    • Clinique Victor Hugo Centre Jean Bernard
  • Lille, France, 59800
    • Hôpital Privé La Louvière
  • Nancy, France, 54100
    • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
  • Paris, France, 75248
    • Institut Curie
  • Plérin, France, 22190
    • Hôpital Privé des Côtes d'Armor
  • Rennes, France, 35042
    • CRLCC Eugene Marquis
• Germany
  • Augsburg, Germany, 86150
    • Gemeinschaftspraxis für Hämatologie & Onkologie
  • Berlin, Germany, 12200
    • Charite Universitatsmedizin Berlin
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus
  • Dusseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Emmendingen, Germany, 79312
    • Urologische Gemeinschaftspraxis
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf (UKE)
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Jena, Germany, 07747
    • Universitätsklinikum Jena
  • Köln, Germany, 50937
    • Universitätsklinik Köln
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein
  • Mannheim, Germany, 68167
    • Medizinischen Fakultät Mannheim der Universität Heidelberg
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie
  • Tuebingen, Germany, 72076
    • University of Tuebingen
  • Wuppertal, Germany, 42103
    • Die Gesundhehitsunion DGU
• Ireland
  • Cork, Ireland, T12 DFK4
    • Cork University Hospital
  • Dublin, Ireland, Dublin 7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, D08 NHY1
    • St James's Hospital
  • Dublin, Ireland, D04T6F4
    • St. Vincent's University Hospital
  • Dublin, Ireland, Dublin 24
    • Adelaide & Meath Hospital, Incorporating the National Children's Hospital
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus (RHCC), Rambam Medical Center
  • Jerusalem, Israel, 71120
    • Hadassah University Hospital
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center-Beilinson Campus
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 64231
    • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
• Italy
  • Arezzo, Italy, 52100
    • Ospedale San Donato, Azienda USLSUDEST
  • Faenza, Italy, 48018
    • Ospedale Santa Maria delle Croci
  • Milano, Italy, 20133
    • Irccs Istituto Nazionale Dei Tumori (Int)
  • Milano, Italy, 20141
    • IEO Instituto Europeo di Oncologia
  • Modena, Italy, 41124
    • University of Modena and Reggio Emilia Medical Oncology
  • Rome, Italy, 00152
    • Azienda Ospedaliera San Camillo-Forlanini
  • Terni, Italy, 05100
    • Azienda Opsedaliera S. Maria di Terni
  • Trento, Italy, 38122
    • Santa Chiara Hospital, Dept Medical Oncology
• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Barcelona, Spain, 08003
    • Hospital del Mar, Servicio de Oncología
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial de Barcelona-Oncology
  • Barcelona, Spain, 08908
    • Instituto Catalan de Oncologia
  • Guadalajara, Spain, 19002
    • Hospital General Universitario de Guadalajara
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti.
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center - Madrid
  • Madrid, Spain, 28222
    • Hospital Puerta de Hierro-Majadahonda
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Sabadell, Spain, 8208
    • Corporacio Sanitaria Parc Tauli
  • Santander, Spain, 39008
    • Marques de Valdecilla University Hospital (HUMV)
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia IVO
• United Kingdom
  • Headington, United Kingdom, OC3 7LJ
    • Oxford University Hospitals
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, N6A 4L6
    • London Health Science Center - Victoria Hospital
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institutute - UK
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
  • Wirral, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Berkshire
    • Slough, Berkshire, United Kingdom, SL2 4HL
      • Wexham Park Hospital
  • England
    • Northwood, England, United Kingdom, HA6 2RN
      • Mount Vernon Cancer Centre
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85259
      • Mayo Clinc
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates
  • California
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
    • Los Angeles, California, United States, 90211
      • University of Southern California
    • Palo Alto, California, United States, 94305
      • Stanford University
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Francisco, California, United States, 94115
      • Pacific Hematology Oncology Associates
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Family Comprehensive Cancer Center
    • San Francisco, California, United States, 94143
      • San Francisco VA Health Care System
    • Santa Rosa, California, United States, 95406
      • Redwood Regional Medical Group
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center (Vallejo)
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • Delaware
    • Newark, Delaware, United States, 19713
      • 4701 Ogletown Stanton Rd.
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Community Hospital, Inc.
    • Fort Myers, Florida, United States, 33980
      • Florida Cancer Specialists
    • Orlando, Florida, United States, 32806
      • University of Florida Health Cancer Center
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Atlanta Urological Group
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Comprehensive Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Cancer Center
    • Bethesda, Maryland, United States, 48202
      • Walter Reed Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Fairview Hospital
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A.
    • Minneapolis, Minnesota, United States, 55417
      • Minnesota Veterans Research Institute
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • HCA Midwest Division - Kansas City
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
    • Omaha, Nebraska, United States, 68130
      • Alegent Health Bergan Mercy Hospital , GU Research Network
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Premier Urology Associates dba/AdvanceMed Research
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park
    • New York, New York, United States, 10016
      • NYU Perlmutter Cancer Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering CC
    • New York, New York, United States, 10065
      • Weill Cornell Medical College/NewYork-Presbyterian Hospital
    • Poughkeepsie, New York, United States, 12301
      • Premier Medical Group of the Hudson Valley PC
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Carolina Urology Partners
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
    • Kettering, Ohio, United States, 45429
      • Kettering Cancer Center
    • Middleburg Heights, Ohio, United States, 44130
      • Clinical Research Solutions
  • Oregon
    • Portland, Oregon, United States, 97219
      • VA Portland Health Care System
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • Consultants in Medical Oncology Hematology
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • SCRI - Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75320
      • Texas Oncology Medical City Dallas
    • Houston, Texas, United States, 77030
      • UT Health Science Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Tyler
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be 18 years old at the time the informed consent form is signed
• Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate
• Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
• Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
• Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

Exclusion Criteria:

• Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
• Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
• Symptomatic and/or untreated central nervous system metastases
• Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rucaparib; Oral rucaparib (monotherapy)	Drug: Rucaparib; Rucaparib will be administered daily; Other Names: CO-338

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)	The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)	A supportive efficacy endpoint is confirmed radiographic ORR by INV. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)	A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator	A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory	A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.	PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory	A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.	PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)	A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator	A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Overall Survival (OS) by Gene	A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.	From date of first dose until event, loss to follow-up, withdrawal of consent, or study closure: an overall median of approximately 33.1 months
Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)	A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Clinical Benefit Rate (CBR) by Gene Per Investigator	A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.	Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Time to PSA Progression by Gene	A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.	PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
Steady State Trough (Cmin) Level Rucaparib Concentrations	Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.	Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113

Collaborators and Investigators

• Sponsor: zr Pharma & GmbH
• Collaborators: Foundation Medicine

Publications and helpful links

General Publications

• Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
• Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): July 18, 2021
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimated): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PARP inhibitor; mCRPC; PALB2; CRPC; BRCA; PARPi; CDK12; germline; HRD; homologous recombination; DNA defect; ATM; DNA repair; DNA anomaly; somatic; RAD51C; RAD51D; BARD1; BRIP1; FANCA; RAD51; RAD51B; TRITON; CHEK2; NBN; RAD54L
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Rucaparib
• Other Study ID Numbers: CO-338-052; 2016-003162-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

• IPD Sharing Time Frame: Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
• IPD Sharing Access Criteria: Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No