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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000518-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Foundation Medicine | INDUSTRY |
| Myriad Genetics, Inc. | INDUSTRY |
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Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
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). Clinical data have shown that ovarian cancer patients with and without evidence of a gBRCA mutation benefit from treatment with a PARP and that maintenance treatment with a PARP inhibitor following a response to platinum-based treatment increases PFS in patients with ovarian cancer. While patients with a BRCA mutation derived the most benefit, patients without evidence of a BRCA mutation also derived significant benefit.
Patients enrolled into this study will be stratified into 3 groups based on tumor HRD status. The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib. It is anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene mutation or other HR gene alteration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rucaparib | Experimental | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
|
| Placebo | Placebo Comparator | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) | Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). | Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS) | To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR). | Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 8.2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Giordano | Clovis Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85704 | United States | ||
| Saint Jude Heritage Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37262961 | Derived | Peipert JD, Goble S, Isaacson J, Tang X, Wallace K, Coleman RL, Ledermann JA, Cella D. Patient-reported outcomes of maintenance rucaparib in patients with recurrent ovarian carcinoma in ARIEL3, a phase III, randomized, placebo-controlled trial. Gynecol Oncol. 2023 Aug;175:1-7. doi: 10.1016/j.ygyno.2023.05.060. Epub 2023 May 30. | |
| 35397664 |
| Label | URL |
|---|---|
| ARIEL program website | View source |
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564 subjects were recruited from 87 sites across 11 countries and randomized (2:1) to treatment with rucaparib or placebo
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| ID | Title | Description |
|---|---|---|
| FG000 | Rucaparib 600 mg Tablets | Taken orally twice daily (continuous 28 day treatment cycles) |
| FG001 | Placebo Tablets | Taken orally twice daily (continuous 28 day treatment cycles) |
| 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 6, 2020 | Oct 20, 2022 |
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|
|
| Placebo | Drug | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
|
| Overall Survival (OS) | Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive. | All patients were followed for survival up to approximately 8.2 years. |
| Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18 | The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy. | Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years. |
| Time to an 8-point Decrease in the Total Score of the FOSI-18 | The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy. | Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years. |
| Individual Model Parameter Estimates of Rucaparib and Covariates Identification | Concentration summary statistics | Study data collection occurred over approximately 7 months. |
| Fullerton |
| California |
| 92835 |
| United States |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| University of California San Francisco (UCSF) | San Francisco | California | 94158 | United States |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93422 | United States |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | United States |
| University of California Los Angeles (UCLA) | Santa Monica | California | 90404 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Florida Hospital | Orlando | Florida | 32804 | United States |
| Johns Hopkins Universty | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute - Wayne State University | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine - Division of Gynaecological Oncology | St Louis | Missouri | 63110 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Hope Women's Cancer Centers | Asheville | North Carolina | 28806 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington at Seattle | Seattle | Washington | 98109 | United States |
| Prince of Wales Hospital | Sydney | New South Wales | 2031 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4029 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3052 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| St John of God Hospital Subiaco | Subiaco | Western Australia | 608 | Australia |
| AZ St Augustinus | Antwerp | 2610 | Belgium |
| UZ Gent | Ghent | B-9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Clinique Sainte-Elisabeth | Namur | 5000 | Belgium |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G1Z2 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V5C2 | 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 |
| CHUM Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2L4M1 | Canada |
| Centre Hospitalier Universitaire de Québec | Québec | G1R2J6 | Canada |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | 69373 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France |
| Centre Francois Baclesse | Caen | Basse-Normandie | 14076 | France |
| Institut Claudius Regaud | Toulouse | Midi-Pyrenees | 31052 | France |
| Centre Catherine de Sienne | Nantes | Pays de la Loire Region | 44202 | France |
| Institute Bergonie | Bordeaux | 33076 | France |
| Hospital Tenon | Paris | 75020 | France |
| Hôpital Européen Georges-Pompidou | Paris | Île-de-France Region | 75908 | France |
| Institut Gustave Roussy | Villejuif | Île-de-France Region | 94805 | France |
| Klinikum Ludwigsburg-Bietigheim gGmbH | Ludwigsburg | Baden-Wuerttembert | 71640 | Germany |
| Klinikum Stuttgart | Stuttgart | Baden-Wurttemberg | 70174 | Germany |
| Rotkreuzklinikum Muenchen gGmbH | Munich | Bavaria | 80637 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | Hesse | 60596 | Germany |
| Dr. Horst Schmidt Klinik, Klinik fuer Gynaekologie und Gyn. Onkologie | Wiesbaden | Hesse | 65199 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | Saxony | 09116 | Germany |
| Technische Universität Dresden | Dresden | Saxony | 01307 | Germany |
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| Lady Davis Carmel Medical Center | Haifa | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Oncology Institute, Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Assaf Harofeh M.C. | Ẕerifin | 70300 | Israel |
| Oncology Unit City Hospital degli Infermi | Faenza | Ravenna | 48018 | Italy |
| Arcispedale Santa Maria Nuova IRCCS | Reggio Emilia | Reggio Nella Emilia | 42100 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Bologna | 40138 | Italy |
| Fondazione IRCCS National Cancer Institute | Milan | 20133 | Italy |
| Instituto Europeo di Oncologia | Milan | 20141 | Italy |
| Azienda Ospedaliero Universitaria Policlinico di Modena | Modena | 41124 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale | Naples | 80131 | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | 00158 | Italy |
| Auckland City Hospital | Auckland | Grafton | 1023 | New Zealand |
| Palmsteron North Hospital | Palmerston North | Manawatu | 4442 | New Zealand |
| Wellington Hospital | Newtown | Wellington Region | 6021 | New Zealand |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Centro Oncologico de Galica | A Coruña | 15009 | Spain |
| Hospital Vall D'Hebron | Barcelona | 8035 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario San Carlos | Madrid | 28040 | Spain |
| Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro | Madrid | 28050 | Spain |
| Hospital Regional Universitario Carlos Haya de Malaga | Málaga | 29011 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Instituto Valencia de Oncologia-Fundacion | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Royal Marsden Hospital | London | England | SW3 6JJ | United Kingdom |
| Belfast City Hospital | Belfast | Northern Ireland | BT9 7AB | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | Scotland | G120YN | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| St. James University Hospital | Leeds | West Yorkshire | LS97TF | United Kingdom |
| Addenbrookes Hospital | Cambridge | CB20QQ | United Kingdom |
| Barts Health NHS Trust | London | EC1M6BQ | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W120HS | United Kingdom |
| Sarah Cannon Reserach Institute UK | London | W1G6AD | 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 |
| 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 | 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. |
| 32861537 | Derived | Colombo N, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Weberpals JI, Clamp AR, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, O'Malley DM, Armstrong DK, Banerjee S, Garcia-Donas J, Swisher EM, Meunier J, Cameron T, Maloney L, Goble S, Bedel J, Ledermann JA, Coleman RL. The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma. Gynecol Oncol. 2020 Oct;159(1):101-111. doi: 10.1016/j.ygyno.2020.05.045. Epub 2020 Aug 26. |
| 32359490 | Derived | Ledermann JA, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Colombo N, Weberpals JI, Clamp AR, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, O'Malley DM, Armstrong DK, Banerjee S, Garcia-Donas J, Swisher EM, Cameron T, Maloney L, Goble S, Coleman RL. Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 May;21(5):710-722. doi: 10.1016/S1470-2045(20)30061-9. |
| 28916367 | Derived | Coleman RL, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Colombo N, Weberpals JI, Clamp A, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, O'Malley DM, Armstrong DK, Garcia-Donas J, Swisher EM, Floquet A, Konecny GE, McNeish IA, Scott CL, Cameron T, Maloney L, Isaacson J, Goble S, Grace C, Harding TC, Raponi M, Sun J, Lin KK, Giordano H, Ledermann JA; ARIEL3 investigators. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Oct 28;390(10106):1949-1961. doi: 10.1016/S0140-6736(17)32440-6. Epub 2017 Sep 12. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rucaparib 600 mg Tablets | Taken orally twice daily (continuous 28 day treatment cycles) |
| BG001 | Placebo Tablets | Taken orally twice daily (continuous 28 day treatment cycles) |
| BG002 | 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 |
| ||||||||||||||||
| Best Response from Previous Platinum Therapy | Complete and partial responses at baseline must have been reported according to RECIST v1.1, as assessed by CT/MRI, and GCIG CA-125 response criteria, and defined as: Complete Response (CR) i.e. absence of any detectable disease and CA-125\ | Count of Participants | Participants |
| |||||||||||||||
| Penultimate Progression-free (PF) Interval | Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). | Count of Participants | Participants |
| |||||||||||||||
| Bulky Lesions (lesion >20 mm) at Baseline | 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 | Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) | Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). | Intent-to-treat: All patients randomized | Posted | Median | 95% Confidence Interval | Months | Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years. |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS) | To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR). | Intent-to-treat: All patients randomized | Posted | Median | 95% Confidence Interval | months | Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 8.2 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive. | Intent-to-treat: All patients randomized | Posted | Median | 95% Confidence Interval | Months | All patients were followed for survival up to approximately 8.2 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18 | The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy. | Intent-to-treat: All patients randomized | Posted | Median | 95% Confidence Interval | Months | Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to an 8-point Decrease in the Total Score of the FOSI-18 | The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy. | Intent-to-treat: All patients randomized | Posted | Median | 95% Confidence Interval | Months | Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual Model Parameter Estimates of Rucaparib and Covariates Identification | Concentration summary statistics | All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Study data collection occurred over approximately 7 months. |
|
|
Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years.
Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug.
Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
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 | Rucaparib 600 mg Tablets | Taken orally twice daily (continuous 28 day treatment cycles) | 9 | 372 | 91 | 372 | 372 | 372 |
| EG001 | Placebo Tablets | Taken orally twice daily (continuous 28 day treatment cycles) | 2 | 189 | 20 | 189 | 182 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal stoma output increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| B-cell unclassifiable lymphoma high grade | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Lung squamous cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | 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_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2017 | May 4, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| 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 |
| D005184 | Fallopian Tube Diseases |
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 |
|
| RECIST / CA-125 PR |
|
| >12 Months |
|
| No |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 2 Day 1 |
| |||||
| Cycle 4 Day 1 |
| |||||
| Cycle 7 Day 1 |
|