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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000517-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Foundation Medicine | INDUSTRY |
| Myriad Genetics, Inc. | INDUSTRY |
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The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.
Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.
Clinical data with PARP inhibitors indicate there is an ovarian cancer patient population beyond just those with germline BRCA (gBRCA) mutations that may benefit from treatment with a PARP inhibitor. This study will define a molecular signature of HRD in ovarian cancer that correlates with response to rucaparib and enables selection of appropriate ovarian cancer patients for treatment with rucaparib. The HRD signature will be based on an association between the extent of genomic scarring (a downstream consequence of HRD) in a patient's tumor and observed clinical benefit from rucaparib treatment. Genomic scarring can be assessed by quantifying the extent of loss of heterozygosity across the tumor genome (tumor genomic LOH). One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors regardless of the underlying mechanisms, which include both known (i.e., BRCA mutations) and unknown genetic and other mechanisms.
Once determined, this signature will be prospectively applied to ARIEL2 PART 2 and ARIEL3. This Phase 2 study (ARIEL2) will also compare archival versus recently collected tumor tissue in order to validate the use of archival tumor tissue for assessment of HRD status in ARIEL3.
This study will include 2 parts:
PART 1 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received ≥1 prior platinum-based regimen and had platinum-sensitive disease
PART 2 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received at least 3 prior chemotherapy regimens
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian cancer | Experimental | rucaparib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral rucaparib | Drug | 600 mg BID |
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|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions. | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
| Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study) | The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed CR or PR on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. |
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The following eligibility criteria pertain to patients enrolling into PART 2 of the study:
Inclusion:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States | ||
| University of Arizona Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 35170751 | Derived |
| Label | URL |
|---|---|
| ARIEL trials website | View source |
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491 subjects were recruited from 64 sites across 6 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: tBRCA | Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor. Part 1 enrolled patients who received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease. |
| FG001 | Part 1: Non-tBRCA LOH+ |
| 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 | Jul 17, 2019 | Sep 18, 2020 |
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| Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
| Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria | The endpoint of ORR defined as the percentage of patients with a best response of CR or PR using RECIST v 1.1 or a response per Gynecologic Cancer InterGroup cancer antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response. | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
| Duration of Response Per RECIST v1.1 | Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of progressive disease (PD) per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
| Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions. | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
| Overall Survival (Part 2 of Study) | Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive. | All patients in Part 2 were followed for survival, subsequent therapy, and secondary malignancy every 12 weeks until death, loss to follow-up, withdrawal of consent from study or study closure, whichever happened first, up to 7 years. |
| Steady State Trough (Cmin) Level Rucaparib Concentrations | Per protocol, the secondary PK endpoint, trough (Cmin) concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected. Blood samples for trough level PK analysis of rucaparib were drawn at the following timepoints only: on Day 15 of Cycle 1 and on Day 1 of Cycles 2, 3, and 4. Data for other timepoints is not available. | Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Saint Jude Heritage Medical Center | Fullerton | California | 92835 | United States |
| University of California Los Angeles | Los Angeles | California | 90404 | United States |
| UC San Diego | San Diego | California | 92093 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | United States |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| UF Health Cancer Center | Orlando | Florida | 32806 | United States |
| Horizon BioAdvance | Lafayette | Indiana | 47905 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40241 | United States |
| Johns Hopkins Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89014 | United States |
| Women's Cancer Care Associates | Albany | New York | 12208 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Hope - A Woman's Cancer Institute | Asheville | North Carolina | 28006 | United States |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45206 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73019 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Royal North Shore Hospital | Saint Leonards | New South Wales | 2065 | Australia |
| Prince of Wales Hospital | Sydney | New South Wales | 2031 | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4029 | Australia |
| Flinders Cancer Clinic - Flinders Medical Centre (FMC) | Bedford Park | South Australia | 5042 | Australia |
| Mercy Hospital for Women | Heidelberg | Victoria | 3084 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3052 | Australia |
| Crown Princess Mary Cancer Centre (Westmead Hospital) | Westmead | Wentworthville | NSW 2145 | Australia |
| Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N4N2 | Canada |
| Cross Cancer Centre | Edmonton | Alberta | T6G1Z2 | Canada |
| British Columbia Cancer Agency | Kelowna | British Columbia | V1Y 5L3 | Canada |
| BC Cancer Agency - Fraser Valley Centre | Surrey | British Columbia | V3V 1Z2 | Canada |
| Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA) | Vancouver | British Columbia | V5Z4E6 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A4L6 | Canada |
| Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G2M9 | Canada |
| Centre Hospitalier de L'Universite de Montreal | Montreal | Quebec | H2L 4M1 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CHU de Québec - Université Laval | Québec | G1R 2J6 | Canada |
| Institut Bergonie | Bordeaux | Aquitaine | 33076 | France |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | 69373 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France |
| Institut Claudius Regaud | Toulouse | Midi-Pyrenees | 31052 | France |
| Centre Catherine de Sienne | Nantes | Pays de la Loire Region | 44202 | France |
| Hopital Tenon | Paris | Île-de-France Region | 75020 | France |
| Hôpital Européen Georges-Pompidou | Paris | Île-de-France Region | 75908 | France |
| Institut de cancerologie Gustave Roussy | Villejuif | Île-de-France Region | 94805 | France |
| Hospital Vall d'Hebron | Barcelona | 8035 | Spain |
| Instituto Valencia de Oncologia | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Beatson West of Scotland Cancer Centre | Glasgow | Scotland | G120YN | United Kingdom |
| Royal Marsden Sutton Hospital | Sutton | Surrey | SM2 5PT | United Kingdom |
| St James University Hospital | Leeds | West Yorkshire | LS97TF | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB20QQ | United Kingdom |
| Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| Imperial College Healthcare NHS Trust - Hammersmith Hospital | London | W120HS | United Kingdom |
| University College London | London | W1T4TJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M204BX | United Kingdom |
| Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care | Newcastle upon Tyne | NE77DN | United Kingdom |
| Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4. |
| 33941784 | Derived | Swisher EM, Kwan TT, Oza AM, Tinker AV, Ray-Coquard I, Oaknin A, Coleman RL, Aghajanian C, Konecny GE, O'Malley DM, Leary A, Provencher D, Welch S, Chen LM, Wahner Hendrickson AE, Ma L, Ghatage P, Kristeleit RS, Dorigo O, Musafer A, Kaufmann SH, Elvin JA, Lin DI, Chambers SK, Dominy E, Vo LT, Goble S, Maloney L, Giordano H, Harding T, Dobrovic A, Scott CL, Lin KK, McNeish IA. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2). Nat Commun. 2021 May 3;12(1):2487. doi: 10.1038/s41467-021-22582-6. |
| 31685558 | Derived | Kristeleit RS, Oaknin A, Ray-Coquard I, Leary A, Balmana J, Drew Y, Oza AM, Shapira-Frommer R, Domchek SM, Cameron T, Maloney L, Goble S, Lorusso D, Ledermann JA, McNeish IA. Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety. Int J Gynecol Cancer. 2019 Nov;29(9):1396-1404. doi: 10.1136/ijgc-2019-000623. |
| 27908594 | Derived | Swisher EM, Lin KK, Oza AM, Scott CL, Giordano H, Sun J, Konecny GE, Coleman RL, Tinker AV, O'Malley DM, Kristeleit RS, Ma L, Bell-McGuinn KM, Brenton JD, Cragun JM, Oaknin A, Ray-Coquard I, Harrell MI, Mann E, Kaufmann SH, Floquet A, Leary A, Harding TC, Goble S, Maloney L, Isaacson J, Allen AR, Rolfe L, Yelensky R, Raponi M, McNeish IA. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017 Jan;18(1):75-87. doi: 10.1016/S1470-2045(16)30559-9. Epub 2016 Nov 29. |
Patients without a BRCA mutation in their tumor, but have high LOH (loss of heterozygosity). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease. |
| FG002 | Part 1: Non-tBRCA LOH- | Patients without a BRCA mutation in their tumor, but have low LOH. Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease. |
| FG003 | Part 1: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease. |
| FG004 | Part 2: tBRCA | Patients with a deleterious BRCA mutation detected in their tumor. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens. |
| FG005 | Part 2: Non-tBRCA LOH+ | Patients without a BRCA mutation in their tumor, but have high LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens. |
| FG006 | Part 2: Non-tBRCA LOH- | Patients without a BRCA mutation in their tumor, but have low LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens. |
| FG007 | Part 2: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | tBRCA | Patients with a deleterious BRCA mutation detected in their tumor. |
| BG001 | Non-tBRCA LOH+ | Patients without a BRCA mutation in their tumor, but have high LOH. |
| BG002 | Non-tBRCA LOH- | Patients without a BRCA mutation in their tumor, but have low LOH. |
| BG003 | Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
| BG004 | 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 | Overall participant count is separated into Part 1 and Part 2 patients. | Median | Full Range | years |
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| Sex: Female, Male | Overall participant count is separated into Part 1 and Part 2 patients. | Count of Participants | Participants |
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| Race (NIH/OMB) | Overall participant count is separated into Part 1 and Part 2 patients. | Count of Participants | Participants |
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| Number of Prior Chemotherapy Regimens | Overall participant count is separated into Part 1 and Part 2 patients. | Count of Participants | Participants |
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| Number of Prior Platinum Regimens | Overall participant count is separated into Part 1 and Part 2 patients. | Count of Participants | Participants |
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| Platinum Sensitivity Status | Refractory = Best response of progressive disease (PD) and PD occurs during or up to 2 months after regimen; Resistant = PD 0-<6 months after last platinum with best response other than PD; Sensitive = PD ≥6 months after last platinum | Overall participant count is separated into Part 1 and Part 2 patients. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) | The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions. | Safety population by HRD subgroups: Consists of all Part 1 patients who received at least one dose of rucaparib. | Posted | Median | 95% Confidence Interval | Days | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
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| Primary | Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib. | Posted | Number | 95% Confidence Interval | percentage of participants | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
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| Secondary | Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study) | The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed CR or PR on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Safety population by HRD subgroups: Consist of all Part 1 patients who received at least one dose of rucaparib | Posted | Number | 95% Confidence Interval | percentage of participants | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
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| Secondary | Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria | The endpoint of ORR defined as the percentage of patients with a best response of CR or PR using RECIST v 1.1 or a response per Gynecologic Cancer InterGroup cancer antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response. | Safety population by HRD subgroups: Consist of all Part 1 and Part 2 patients who received at least one dose of rucaparib. | Posted | Number | 95% Confidence Interval | percentage of patients | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
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| Secondary | Duration of Response Per RECIST v1.1 | Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of progressive disease (PD) per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Efficacy population by HRD subgroups. The overall number of patients analyzed includes only patients with confirmed RECIST CR or PR. | Posted | Median | 95% Confidence Interval | Days | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
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| Secondary | Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) | Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions. | Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib. | Posted | Median | 95% Confidence Interval | Days | Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. |
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| Secondary | Overall Survival (Part 2 of Study) | Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive. | Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib. | Posted | Median | 95% Confidence Interval | Months | All patients in Part 2 were followed for survival, subsequent therapy, and secondary malignancy every 12 weeks until death, loss to follow-up, withdrawal of consent from study or study closure, whichever happened first, up to 7 years. |
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| Secondary | Steady State Trough (Cmin) Level Rucaparib Concentrations | Per protocol, the secondary PK endpoint, trough (Cmin) concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected. Blood samples for trough level PK analysis of rucaparib were drawn at the following timepoints only: on Day 15 of Cycle 1 and on Day 1 of Cycles 2, 3, and 4. Data for other timepoints is not available. | All Part 1 and Part 2 patients with at least one PK sample collected | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks |
|
|
Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug, approximately 5 years.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Adverse Events were monitored/assessed without regard to the subgroups.
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 | Part 1 Overall | All patients who participated in Part 1 who received at least one dose of rucaparib | 2 | 204 | 54 | 204 | 203 | 204 |
| EG001 | Part 2 Overall | All patients who participated in Part 2 who received at least one dose of rucaparib | 18 | 287 | 92 | 287 | 285 | 287 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Granulocytosis | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac congestive failure | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Long QT syndrome congenital | Congenital, familial and genetic disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hepatic haematoma | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | 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 | May 16, 2019 | Sep 18, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D005184 | Fallopian Tube Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C531549 | rucaparib |
Not provided
Not provided
Not provided
|
| Part 2 |
|
|
|
| Part 2 |
|
|
|
| Part 2 |
|
|
|
| Part 2 |
|
|
|
| Part 2 |
|
|
|
| Part 2 |
|
|
| Cox Proportional Hazard |
| 0.610 |
| 2-Sided |
| 95 |
| 0.428 |
| 0.871 |
| Superiority |
Patients without a BRCA mutation in their tumor, but have low LOH. |
| OG003 | Part 2: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
|
|
Patients without a BRCA mutation in their tumor, but have low LOH.
| OG003 | Part 1: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
|
|
Patients without a BRCA mutation in their tumor, but have high LOH. |
| OG002 | Part 1: Non-tBRCA LOH- | Patients without a BRCA mutation in their tumor, but have low LOH. |
| OG003 | Part 1: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
| OG004 | Part 2: tBRCA | Patients with a deleterious BRCA mutation detected in their tumor. |
| OG005 | Part 2: Non-tBRCA LOH+ | Patients without a BRCA mutation in their tumor, but have high LOH. |
| OG006 | Part 2: Non-tBRCA LOH- | Patients without a BRCA mutation in their tumor, but have low LOH. |
| OG007 | Part 2: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
|
|
| Part 1: Non-tBRCA LOH- |
Patients without a BRCA mutation in their tumor, but have low LOH. |
| OG003 | Part 1: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
| OG004 | Part 2: tBRCA | Patients with a deleterious BRCA mutation detected in their tumor. |
| OG005 | Part 2: Non-tBRCA LOH+ | Patients without a BRCA mutation in their tumor, but have high LOH. |
| OG006 | Part 2: Non-tBRCA LOH- | Patients without a BRCA mutation in their tumor, but have low LOH. |
| OG007 | Part 2: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
|
|
| OG003 | Part 2: Non-tBRCA LOH Unknown | Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
|
|
Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). |
|
|
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| >5 |
|
| 1 |
|
| 2 |
|
| 3 |
|
| >3 |
|
| Resistant |
|
| Sensitive |
|