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Rucaparib

Phase 3

Metastatic Castration-resistant Prostate Cancer | Small molecule | Other |Bayer AG|Trials Updated: May 4, 2025

Rucaparib development status

Highest phase Phase 3 run by pharmaand GmbH (NCT01968213)
Phase scored for BAYRYPhase 1
Registered trials 19 across 12 sponsors since Feb 2016

Rucaparib target and mechanism

ModalitySmall molecule

Also known as Rubraca

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Rucaparib clinical trials

Rucaparib · 1 trial · 1 indication

Phase 1/2 1
NCT04253262A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer
ACTIVE NOT_RECRUITING13 Analytics
PHASE1/PHASE2ACTIVE NOT_RECRUITING
A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
NCT0425326213
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Study Endpoints

Primary Endpoints

Maximum Tolerated Dose
Cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month.

To evaluate the maximum tolerated dose of copanlisib with rucaparib in patients with metastatic castration-resistant prostate cancer.

Response
Every 28 days on treatment, then every 3 months until progression of disease up to 3 years.

To estimate the overall response rate of the combination of copanlisib and rucaparib in patients with metastatic castration-resistant prostate cancer.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Level -2EXPERIMENTAL300 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib
Dose Level -1EXPERIMENTAL400 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib
Dose Level 1EXPERIMENTAL400 mg Rucaparib, 45 mg Copanlisib
Dose Level 2EXPERIMENTAL500 mg Rucaparib, 45 mg Copanlisib
Dose Level 3EXPERIMENTAL600 mg Rucaparib, 45 mg Copanlisib
Dose Level 4EXPERIMENTAL600 mg Rucaparib, 60 mg Copanlisib

Interventions

NameTypeDescription
RucaparibDRUGRucaparib (PO twice daily continuous)
CopanlisibDRUGCopanlisib (IV day 1, 8, 15; 28 day cycle)
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria 1. Age ≥ 18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 3. Life expectancy of at least 3 months 4. Histologically confirmed prostate cancer. Treatment-emergent small cell/NEPC (neuroendocrine prostate cancer) is allowed, but de novo small cell car...

Countries:United States
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