Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004166-10 | EudraCT Number |
Not provided
Not provided
Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.
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| Name | Class |
|---|---|
| Foundation Medicine | INDUSTRY |
Not provided
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The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rucaparib | Experimental | Oral rucaparib (monotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | Rucaparib will be administered daily. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST Version 1.1 | ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. 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. | Time from first dose to date of progression, up to approximately 19 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator | 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. | Cycle 1 Day 1 to End of Treatment, up to approximately 10 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Oncology, Honor Health | Scottsdale | Arizona | 85258 | United States | ||
| University of California San Diego (UCSD), Moores Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34030643 | Derived | Grivas P, Loriot Y, Morales-Barrera R, Teo MY, Zakharia Y, Feyerabend S, Vogelzang NJ, Grande E, Adra N, Alva A, Necchi A, Rodriguez-Vida A, Gupta S, Josephs DH, Srinivas S, Wride K, Thomas D, Simmons A, Loehr A, Dusek RL, Nepert D, Chowdhury S. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS). BMC Cancer. 2021 May 24;21(1):593. doi: 10.1186/s12885-021-08085-z. |
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97 subjects were recruited from 40 sites across 6 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | HRD Unknown | Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown. |
| FG001 | HRD Negative |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2018 | Jul 28, 2020 |
Not provided
Not provided
Not provided
Not provided
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| Overall Survival | Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure). | The total study time for reporting of deaths was approximately 19 months. |
| Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations | Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1. | From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months |
| La Jolla |
| California |
| 92093 |
| United States |
| University of California, Los Angeles (UCLA) | Los Angeles | California | 90095 | United States |
| Universityof California, Irvine | Orange | California | 92868 | United States |
| Saint John's Health Center - John Wayne Cancer Institute (JWCI) | Santa Monica | California | 90404 | United States |
| Stanford University School of Medicine | Stanford | California | 94304 | United States |
| Hartford Health Care Cancer Institute | Hartford | Connecticut | 06102 | United States |
| Eastern Connecticut Hematology & Oncology Associates (ECHO) | Norwich | Connecticut | 06360 | United States |
| Medstar Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Miami Cancer Institute, Baptist Health South Florida | Miami | Florida | 33176 | United States |
| Northwestern University, Chicago | Chicago | Illinois | 60611 | United States |
| Indiana University - Melvin and Bren Simon Cancer Center (IUSCC) | Indianapolis | Indiana | 46202 | United States |
| The University of Iowa and Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| Norton Cancer Center | Louisville | Kentucky | 40207 | United States |
| Ochsner Cancer Institute | New Orleans | Louisiana | 70121 | United States |
| University of Maryland, Marlene and Stewart Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Oncology Hematology P.A. (USO - US Oncology) | Minneapolis | Minnesota | 55404 | United States |
| Comprehensive Cancer Centers of Nevada (CCCN) | Las Vegas | Nevada | 89169 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico UNM Cancer Research and Treatment Center | Albuquerque | New Mexico | 87102 | United States |
| New York Oncology Hematology, P.C. (USO - US Oncology) | Albany | New York | 12208 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| New York - Presbyterian Hospital-Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University, Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Northwest Cancer Specialists P.C. (USO - US Oncology) | Portland | Oregon | 97062 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Atlantic Urology Clinics | Myrtle Beach | South Carolina | 29572 | United States |
| University Oncology & Hematology | Chattanooga | Tennessee | 37403 | United States |
| Urology Associates | Nashville | Tennessee | 37209 | United States |
| Texas Oncology PA (USO - US Oncology) | Dallas | Texas | 76201 | United States |
| University of Texas, UT Health Science Center | Houston | Texas | 77030 | United States |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| University of Virginia, Emily Couric Clinical Center | Charlottesville | Virginia | 22908 | United States |
| University of Washington / Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard | Lyon | 69008 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau | Saint-Herblain | 44805 | France |
| Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Urologische und Kinderurologische Universitätsklinik im Malteser | Erlangen | 91054 | Germany |
| Universitatsklinikum Munster / Urologie und Kinderurologie | Münster | 26133 | Germany |
| Studienpraxis Urologie | Nürtingen | 72622 | Germany |
| Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS | Candiolo | 10060 | Italy |
| IRCCS Ospedale San Raffaele - Medical Oncology Dept | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale Tumori | Milan | 20133 | Italy |
| Azienda Ospedaliera Universitaria Federico II Oncologia Medica | Naples | 80131 | Italy |
| Universidad de Navarra - Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron de Barcelona | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Clinica Universitaria de Navarra Madrid | Madrid | 28027 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Sarah Cannon Research Institute - United Kingdom - London Office | London | CH63 4JY | United Kingdom |
| Guy's & St. Thomas' Hospital (London Oncology Clinic) | London | W1G 6AF | United Kingdom |
Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative. |
| FG002 | HRD Positive | Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HRD Unknown | Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown. |
| BG001 | HRD Negative | Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative. |
| BG002 | HRD Positive | Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive. |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per RECIST Version 1.1 | ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. 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. | Intent-to-treat Population (ITT) with measurable disease at Baseline - The ITT population includes all patients who received at least 1 dose of rucaparib. One patient each in the HRD negative and HRD positive groups did not have measurable disease at Baseline. | Posted | Count of Participants | Participants | Time from first dose to date of progression, up to approximately 19 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator | 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. | Intent-to-Treat population - all patients who received at least 1 dose of rucaparib | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 to End of Treatment, up to approximately 10 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure). | Intent-to-Treat population - all patients who received at least 1 dose of rucaparib | Posted | Count of Participants | Participants | The total study time for reporting of deaths was approximately 19 months. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations | Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1. | Safety population - all patients who received at least 1 dose of rucaparib and who had at least 1 PK sample collected. The number analyzed at each timepoint includes only those participants who remained on study and with viable samples collected at that timepoint. | Posted | Mean | Standard Deviation | ng/mL | From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months |
|
Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HRD Unknown | Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown. | 9 | 47 | 20 | 47 | 45 | 47 |
| EG001 | HRD Negative | Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative. | 8 | 30 | 14 | 30 | 29 | 30 |
| EG002 | HRD Positive | Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive. | 7 | 20 | 11 | 20 | 19 | 20 |
| EG003 | Overall | All patients | 24 | 97 | 45 | 97 | 93 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pubic pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Localized oedema | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
The study was terminated early based on an interim analysis by the Data Monitoring Committee that demonstrated that ORR did not meet the protocol-defined continuance criteria. There were no confirmed responses observed.
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 | Jan 31, 2018 | Jul 28, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D014516 | Ureteral Neoplasms |
| D014523 | Urethral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014515 | Ureteral Diseases |
| D014522 | Urethral Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C531549 | rucaparib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Overall | All patients |
|
|
| OG002 |
| HRD Positive |
Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive. |
| OG003 | Overall | All patients |
|
|
| OG003 | Overall | All patients |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|