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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001538-37 | EudraCT Number |
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This protocol is designed to provide participants currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Participants in long-term follow-up (LTFU) in a parent study may also enroll in this study for continued data collection, as applicable based on parent study objectives.
Participants enrolled in this study are required to have completed an End-of-Treatment (EOT) Visit with associated assessments as specified in the Clovis-sponsored parent study (NCT01891344; NCT01968213; NCT02855944). Participants who are no longer receiving treatment and are in LTFU in the parent study (NCT02855944) may enroll into the LTFU portion of this study, as applicable based on parent study objectives, without repeating the EOT visit.
The starting dose of rucaparib administered at initiation of this study will be the same as the last dose received in the parent study, or as deemed appropriate by the investigator and based on available dose strength tablets. The first treatment in the rollover study will begin at the next scheduled treatment visit following the EOT Visit in the parent study.
Participants enrolled to receive continued rucaparib may be treated until disease progression, as assessed by the investigator, unacceptable toxicity, withdrawal of consent, death, loss to follow-up, or study closure by the sponsor. If a participant demonstrates disease progression per investigator assessment while receiving treatment with rucaparib but continues to derive clinical benefit, then continuation of treatment beyond progression is permitted based on investigator decision and participant consent. If a participant continues treatment post-progression, all study assessments should be continued per institutional standard of care. The participant should be discontinued from treatment once it is clear that no further clinical benefit can be achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rucaparib | Experimental | Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision. |
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| Long-term Follow-up | No Intervention | Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | Rucaparib will be administered daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing SAEs and AESIs | An SAE was any untoward medical occurrence that occurred at any dose, or after informed consent was given and prior to dosing if the SAE was related to a study procedure, that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly or birth defect; or was an important medical event that may not have resulted in death, was not life-threatening, or did not require hospitalization but may be considered an SAE, based on appropriate medical judgment. An AESI was defined as any AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. A summary of all SAEs regardless of causality is located in the 'Reported Adverse Events' Section. | From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months) |
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Inclusion Criteria:
Exclusion Criteria (applicable only to participants considered for continuation of rucaparib treatment):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Regional Cancer Centre | London | Ontario | Canada | |||
| Institut De Recherche De L'Hospital D'Ottawa |
Only serious adverse event (SAE) and adverse event of special interest (AESI) safety data were collected, other (non-serious) adverse events (AEs) were not collected. Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study).
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| ID | Title | Description |
|---|---|---|
| FG000 | Rucaparib | Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision. |
| FG001 | Long-term Follow-up | Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2020 | Apr 3, 2024 |
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| Ottawa |
| Ontario |
| Canada |
| Princess Margaret Hospital - Toronto | Toronto | Ontario | Canada |
| Centre Hospitalier de L'Universite de Montreal (CHUM) | Montreal | Quebec | Canada |
| CIUSSS de l'Estrie - CHUS | Sherbrooke | Quebec | Canada |
| Carmel Medical Center | Haifa | Israel |
| Meir Medical Center | Kfar Saba | Israel |
| Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo | Candiolo | Torino | Italy |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi | Bologna | Italy |
| Istituto Europeo di Oncologia | Milan | Italy |
| Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica | Naples | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | Italy |
| Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie | Bialystok | Podlaskie Voivodeship | Poland |
| Wojewódzki Szpital Specjalistyczny w Olsztynie | Olsztyn | Warmian-Masurian Voivodeship | Poland |
| Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan | Ufa | Bashkortosta | Russia |
| State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region | Sochi | Krasnodarskiy Kray | Russia |
| Arkhangelsk Clinical Oncological Dispensary | Arkhangel'sk | Primorskiy (Maritime) Kray | Russia |
| Republican oncological dispensary of Republic of Mordovia | Saransk | Respublika Mordoviya | Russia |
| Pyatigorsk Oncological Dispensary | Pyatigorsk | Stavropol Kray | Russia |
| N.N. Blokhin Russian Cancer Research Center | Moscow | Russia |
| Omsk Regional Clinical Oncologic Dispensary | Omsk | Russia |
| Ryazan Regional Clinical Oncology Dispensary | Ryazan | Russia |
| Almazov National Medical Research Centre | Saint Petersburg | Russia |
| University College London Hospitals | London | England | United Kingdom |
| East and North Hertfordshire NHS Trust | Middlesex | England | United Kingdom |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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Enrolled Population: all participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rucaparib | Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision. |
| BG001 | Long-term Follow-up | Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing SAEs and AESIs | An SAE was any untoward medical occurrence that occurred at any dose, or after informed consent was given and prior to dosing if the SAE was related to a study procedure, that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly or birth defect; or was an important medical event that may not have resulted in death, was not life-threatening, or did not require hospitalization but may be considered an SAE, based on appropriate medical judgment. An AESI was defined as any AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. A summary of all SAEs regardless of causality is located in the 'Reported Adverse Events' Section. | Safety Population: all participants who received rucaparib during the study (Rucaparib arm), safety data were not collected for the Long-term Follow-up arm. | Posted | Count of Participants | Participants | From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months) |
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From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
Only SAE and AESI safety data were collected, other (non-serious) AEs were not collected. Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study). Data reported for Safety Population: all participants who received rucaparib during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rucaparib | Participants received rucaparib at a dose and schedule last taken in the parent study, or per investigator decision. | 0 | 20 | 2 | 20 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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Only SAE and AESI safety data were collected, other (non-serious) AEs were not collected. Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study).
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 | pharmaand GmbH | +43/1/3560006 | medinfo@pharmaand.com |
| Prot_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D011471 | Prostatic 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D005184 | Fallopian Tube Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
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| ID | Term |
|---|---|
| C531549 | rucaparib |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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