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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003162-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Foundation Medicine | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rucaparib | Experimental | Oral rucaparib (monotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | Rucaparib will be administered daily |
|
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37277275 | Derived | Abida W, Campbell D, Patnaik A, Bryce AH, Shapiro J, Bambury RM, Zhang J, Burke JM, Castellano D, Font A, Ganju V, Hardy-Bessard AC, McDermott R, Sautois B, Spaeth D, Voog E, Piulats JM, Pintus E, Ryan CJ, Merseburger AS, Daugaard G, Heidenreich A, Fizazi K, Loehr A, Despain D, Simmons AD, Dowson M, Go J, Watkins SP, Chowdhury S. Rucaparib for the Treatment of Metastatic Castration-resistant Prostate Cancer Associated with a DNA Damage Repair Gene Alteration: Final Results from the Phase 2 TRITON2 Study. Eur Urol. 2023 Sep;84(3):321-330. doi: 10.1016/j.eururo.2023.05.021. Epub 2023 Jun 3. | |
| 36898948 |
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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.
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.
Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.
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A total of 277 patients were recruited from 102 sites across 12 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | BRCA Mutation | Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor. |
| FG001 | ATM Mutation | Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2020 | Mar 31, 2022 |
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| 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 |
| Phoenix |
| Arizona |
| 85259 |
| United States |
| Arizona Oncology Associates | Tucson | Arizona | 85704 | United States |
| Alliance Research Centers | Laguna Hills | California | 92653 | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| University of Southern California | Los Angeles | California | 90211 | United States |
| Stanford University | Palo Alto | California | 94305 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| San Francisco VA Health Care System | San Francisco | California | 94143 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | United States |
| Redwood Regional Medical Group | Santa Rosa | California | 95406 | United States |
| Kaiser Permanente Medical Center (Vallejo) | Vallejo | California | 94589 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| 4701 Ogletown Stanton Rd. | Newark | Delaware | 19713 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Boca Raton Community Hospital, Inc. | Boca Raton | Florida | 33486 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33980 | United States |
| University of Florida Health Cancer Center | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Atlanta Urological Group | Atlanta | Georgia | 30312 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Walter Reed Hospital | Bethesda | Maryland | 48202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Fairview Hospital | Edina | Minnesota | 55435 | United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55404 | United States |
| Minnesota Veterans Research Institute | Minneapolis | Minnesota | 55417 | United States |
| HCA Midwest Division - Kansas City | Kansas City | Missouri | 64132 | United States |
| Alegent Health Bergan Mercy Hospital , GU Research Network | Omaha | Nebraska | 68130 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89119 | United States |
| Premier Urology Associates dba/AdvanceMed Research | Lawrenceville | New Jersey | 08648 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Roswell Park | Buffalo | New York | 14263 | United States |
| NYU Perlmutter Cancer Center | New York | New York | 10016 | United States |
| Memorial Sloan Kettering CC | New York | New York | 10065 | United States |
| Weill Cornell Medical College/NewYork-Presbyterian Hospital | New York | New York | 10065 | United States |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12301 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Carolina Urology Partners | Concord | North Carolina | 28025 | United States |
| The Urology Group | Cincinnati | Ohio | 45212 | United States |
| Kettering Cancer Center | Kettering | Ohio | 45429 | United States |
| Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | United States |
| VA Portland Health Care System | Portland | Oregon | 97219 | United States |
| Consultants in Medical Oncology Hematology | Horsham | Pennsylvania | 19044 | United States |
| SCRI - Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Texas Oncology Medical City Dallas | Dallas | Texas | 75320 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| UT Health Science Center | Houston | Texas | 77030 | United States |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| VA Puget Sound | Seattle | Washington | 98108 | United States |
| Northern Cancer Insitute, St. Leonards | Saint Leonards | New South Wales | 2065 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Peninsula & Southeast Oncology | Frankston | Victoria | 3199 | Australia |
| Barwon Health, University Hospital Geelong | Geelong | Victoria | 3220 | Australia |
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Southside Cancer Care Centre | Miranda | 2228 | Australia |
| Orange Health Services | Orange | 2800 | Australia |
| St John of God Hospital, Subiaco | Subiaco | 6008 | Australia |
| Riverina Cancer Care Centre | Wagga Wagga | 2650 | Australia |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | B-9000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Equipe de Recherche Clinique, Département d'Oncologie/Hématologie | Liège | 4000 | Belgium |
| AZ DELTA | Roeselare | B-8800 | Belgium |
| Juravinski Cancer Centre Hamilton Health Services | Hamilton | Ontario | L8V5C2 | Canada |
| London Health Science Center - Victoria Hospital | London | Ontario | N6A 4L6 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H8L6 | Canada |
| Princess Margaret Hospital | Toronto | M5G 2M9 | Canada |
| Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| Centre François Baclesse | Caen | 14000 | France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| Clinique Victor Hugo Centre Jean Bernard | Le Mans | 72000 | France |
| Hôpital Privé La Louvière | Lille | 59800 | France |
| Polyclinique de Gentilly (Centre D'Oncologie De Gentilly) | Nancy | 54100 | France |
| Institut Curie | Paris | 75248 | France |
| Hôpital Privé des Côtes d'Armor | Plérin | 22190 | France |
| CRLCC Eugene Marquis | Rennes | 35042 | France |
| Gemeinschaftspraxis fur Hamatologie & Onkologie | Augsburg | 86150 | Germany |
| Charite Universitatsmedizin Berlin | Berlin | 12200 | Germany |
| Universitätsklinik Köln | Cologne | 50937 | Germany |
| Universitatsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Urologische Gemeinschaftspraxis | Emmendingen | 79312 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf (UKE) | Hamburg | 20246 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitatsklinikum Jena | Jena | 07747 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Medizinischen Fakultät Mannheim der Universität Heidelberg | Mannheim | 68167 | Germany |
| Studienpraxis Urologie | Nürtingen | 72622 | Germany |
| University of Tuebingen | Tübingen | 72076 | Germany |
| Die Gesundhehitsunion DGU | Wuppertal | 42103 | Germany |
| Cork University Hospital | Cork | T12 DFK4 | Ireland |
| St. Vincent's University Hospital | Dublin | D04T6F4 | Ireland |
| St James's Hospital | Dublin | D08 NHY1 | Ireland |
| Adelaide & Meath Hospital, Incorporating the National Children's Hospital | Dublin | Dublin 24 | Ireland |
| Mater Misericordiae University Hospital | Dublin | Dublin 7 | Ireland |
| Rambam Health Care Campus (RHCC), Rambam Medical Center | Haifa | 3109601 | Israel |
| Hadassah University Hospital | Jerusalem | 71120 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| The Tel Aviv Sourasky Medical Center (Ichilov Hospital) | Tel Aviv | 64231 | Israel |
| Ospedale San Donato, Azienda USLSUDEST | Arezzo | 52100 | Italy |
| Ospedale Santa Maria delle Croci | Faenza | 48018 | Italy |
| IRCCS Istituto Nazionale dei Tumori (INT) | Milan | 20133 | Italy |
| IEO Instituto Europeo di Oncologia | Milan | 20141 | Italy |
| University of Modena and Reggio Emilia Medical Oncology | Modena | 41124 | Italy |
| Azienda Ospedaliera San Camillo-Forlanini | Rome | 00152 | Italy |
| Azienda Opsedaliera S. Maria di Terni | Terni | 05100 | Italy |
| Santa Chiara Hospital, Dept Medical Oncology | Trento | 38122 | Italy |
| Hospital Universitari Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital del Mar, Servicio de Oncología | Barcelona | 08003 | Spain |
| Hospital Clínic i Provincial de Barcelona-Oncology | Barcelona | 08036 | Spain |
| Instituto Catalan de Oncologia | Barcelona | 08908 | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital General Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Hospital Universitario Lucus Augusti. | Lugo | 27003 | Spain |
| MD Anderson Cancer Center - Madrid | Madrid | 28033 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Puerta de Hierro-Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | 8208 | Spain |
| Marques de Valdecilla University Hospital (HUMV) | Santander | 39008 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Instituto Valenciano de Oncologia IVO | Valencia | 46009 | Spain |
| Wexham Park Hospital | Slough | Berkshire | SL2 4HL | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | England | HA6 2RN | United Kingdom |
| Royal Marsden Hospital | Sutton | Surrey | SM2 5PT | United Kingdom |
| Oxford University Hospitals | Headington | OC3 7LJ | United Kingdom |
| Royal Liverpool Hospital | Liverpool | L7 8XP | United Kingdom |
| London Health Science Center - Victoria Hospital | London | N6A 4L6 | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Sarah Cannon Research Institutute - UK | London | W1G 6AD | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| Derived |
| Collins K, Cheng L. Reprint of: morphologic spectrum of treatment-related changes in prostate tissue and prostate cancer: an updated review. Hum Pathol. 2023 Mar;133:92-101. doi: 10.1016/j.humpath.2023.02.007. Epub 2023 Mar 8. |
| 35397664 | Derived | 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. |
| 32203306 | Derived | 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. |
| FG002 | CDK12 Mutation | Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor. |
| FG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| FG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BRCA Mutation | Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor. |
| BG001 | ATM Mutation | Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor. |
| BG002 | CDK12 Mutation | Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor. |
| BG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| BG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | IRR Efficacy Population - The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 | 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. | Investigator Efficacy Population - The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator (INV). | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | 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. | Patients with a confirmed response in the IRR Efficacy Population. The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review. Note, there were no patients with confirmed response by IRR in the ATM, CDK12 and CHEK2 arms. | Posted | Median | 95% Confidence Interval | 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. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Patients with a confirmed response in the Investigator Efficacy Population. The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator. Note, there were no patients with confirmed response by investigator in the CDK12 arm. | Posted | Median | 95% Confidence Interval | 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. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients who had a PSA value at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients who had a PSA value at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients | Posted | Median | 95% Confidence Interval | 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. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients | Posted | Median | 95% Confidence Interval | 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. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Population - The safety population consists of all patients who received at least 1 dose of protocol-specified treatment. | Posted | Median | 95% Confidence Interval | months | 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 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients | Posted | Count of Participants | Participants | 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 | 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. | All patients | Posted | Count of Participants | Participants | 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 | 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. | All patients who had a PSA value at baseline. | Posted | Median | 95% Confidence Interval | months | 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. |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population with at least one PK sample collected. The safety population consists of all patients who received at least 1 dose of protocol-specified treatment. | Posted | Median | Standard Deviation | ng/mL | Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113 |
|
Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | All patients received open-label oral rucaparib 600 mg BID (twice a day) in continuous 28-day cycles. | 8 | 277 | 96 | 277 | 274 | 277 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Legionella infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Paraspinal abscess | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract stoma complication | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sacral radiculopathy | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Althralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Department | Clovis Oncology, Inc. | +1 415 409 7220 | medinfo@clovisoncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2019 | Mar 31, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C563150 | Mental Retardation, X-Linked, With Or Without Seizures, Arx-Related |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C531549 | rucaparib |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor. |
| OG002 | CDK12 Mutation | Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor. |
| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
|
|
|
|
| OG002 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG003 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
|
|
| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
|
|
| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
|
|
Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
|
|
Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
|
|
Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
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| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
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| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
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| OG003 | CHEK2 Mutation | Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor. |
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
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Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
| OG004 | Other Gene Mutation | Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor. |
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