Metastatic Castration-Resistant Prostate CancerPhase 3CATCH-RNCT04676334
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
A Phase 3 study testing Rucaparib in people with Metastatic Castration-Resistant Prostate Cancer and Ovarian Cancer, run by pharmaand GmbH at 25 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer, Ovarian Cancer, Epithelial Ovarian Cancer
- What is being tested?
- Rucaparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 22 Mar 2021to 8 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently enrolled in a Clovis-sponsored study of rucaparib that is being closed
- Either: (a) Is currently tolerating a rucaparib treatment regimen in the parent study with evidence of clinical benefit, as assessed by the investigator, or (b) Has discontinued treatment and is being followed for collection of LTFU data in the parent study
- Demonstrated compliance with the parent study requirements, as assessed by the investigator, and participant is able and willing to comply with the necessary study visits and assessments as part of the rollover study
- Provided written informed consent prior to enrolling in this rollover study
- Exclusion Criteria (applicable only to participants considered for continuation of rucaparib treatment):
- Participant has been permanently discontinued from study treatment in the parent study for any reason
- Pregnant or breastfeeding female patients
- Presence of any other condition that may, in the opinion of the investigator, make the participant inappropriate for continuation of rucaparib treatment.
Who cannot join
None listed.
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
Russia9 sites
Arkhangelsk Clinical Oncological Dispensary
Arkhangel'sk, Primorskiy (Maritime) Kray
N.N. Blokhin Russian Cancer Research Center
Moscow
Omsk Regional Clinical Oncologic Dispensary
Omsk
Pyatigorsk Oncological Dispensary
Pyatigorsk, Stavropol Kray
Ryazan Regional Clinical Oncology Dispensary
Ryazan
Almazov National Medical Research Centre
Saint Petersburg
Republican oncological dispensary of Republic of Mordovia
Saransk, Respublika Mordoviya
State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
Sochi, Krasnodarskiy Kray
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
Ufa, Bashkortosta
Canada5 sites
London Regional Cancer Centre
London, Ontario
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec
Institut De Recherche De L'Hospital D'Ottawa
Ottawa, Ontario
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec
Princess Margaret Hospital - Toronto
Toronto, Ontario
Italy5 sites
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna
Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo
Candiolo, Torino
Istituto Europeo di Oncologia
Milan
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
Naples
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Poland2 sites
Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie
Bialystok, Podlaskie Voivodeship
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship
United Kingdom2 sites
University College London Hospitals
London, England
East and North Hertfordshire NHS Trust
Middlesex, England
About this study
Official title: CATCH-R: A Rollover Study to Provide Continued Access to Clinical Therapy With Rucaparib
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.
Read the detailed description
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.
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Other Solid Tumor
- Being tested
- Rucaparib
- Keywords
- rucaparib, mCRPC, ovarian cancer, PARP inhibitor, PARPi, CRPC, solid tumor, Clovis Oncology, Antineoplastic agents, Genital Neoplasms, male, Prostatic Neoplasms, Ovarian Neoplasms
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Genital Neoplasms, Male, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RucaparibDrug
Also called CO-338, Rubraca
Rucaparib will be administered daily.
| Study group | Role | What they receive |
|---|---|---|
| Rucaparib | Experimental | Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision. Receives: Drug: Rucaparib |
| Long-term Follow-up | No intervention | Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start22 Mar 2021
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- pharmaand GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676334
- Sponsor's protocol ID
- CO-338-111
- Other IDs
- 2020-001538-37
- Acronym
- CATCH-R
- Status last verified
- Apr 2024
- First submitted
- 14 Dec 2020
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CATCH-R: A Rollover Study to Provide Continued Access to Clinical Therapy With Rucaparib
- ClinicalTrials.gov ID
- NCT04676334
- Acronym / sponsor ID
- CATCH-R / CO-338-111
- Conditions
- Metastatic Castration-Resistant Prostate Cancer, Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Other Solid Tumor
- Keywords
- rucaparib, mCRPC, ovarian cancer, PARP inhibitor, PARPi, CRPC, solid tumor, Clovis Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- pharmaand GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 7 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rucaparib | Experimental | Drug: RucaparibRucaparib administered at dose and schedule last taken in parent study, or per investigator decision. |
| Long-term Follow-up | No intervention | –Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Currently enrolled in a Clovis-sponsored study of rucaparib that is being closed
- Either: (a) Is currently tolerating a rucaparib treatment regimen in the parent study with evidence of clinical benefit, as assessed by the investigator, or (b) Has discontinued treatment and is being followed for collection of LTFU data in the parent study
- Demonstrated compliance with the parent study requirements, as assessed by the investigator, and participant is able and willing to comply with the necessary study visits and assessments as part of the rollover study
- Provided written informed consent prior to enrolling in this rollover study
- Exclusion Criteria (applicable only to participants considered for continuation of rucaparib treatment):
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RucaparibAlso: CO-338, RubracaRucaparib will be administered daily. | Drug | Rucaparib |
Primary outcome
Number of Participants Experiencing SAEs and AESIs
Time frame: From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rucaparib in people with Metastatic Castration-Resistant Prostate Cancer and Ovarian Cancer, run by pharmaand GmbH at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Russia, Canada, Italy, Israel, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing SAEs and AESIs (time frame: From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.