Table 3:
Clinical Trials with Rucaparib in Prostate Cancer
| Clinical Trial Name | NCI Study Number | Patient Population | Phase | Primary Endpoint | Intervention | Biomarker Selected Enrollment* | Estimated Number of Patients |
|---|---|---|---|---|---|---|---|
| Metastatic Disease | |||||||
| CASPAR | NCT04455750 | CRPC | 3 | rPFS | E+R vs E | No | 1002 |
| TRITON3 | NCT02975934 | CRPC | 3 | rPFS | R vs Physician Choice | Yes | 400 |
| CheckMate 9KD | NCT03338790 | CRPC | 2 | ORR, PSA-RR | N+R vs N+D vs N+E | No | 330 |
| TRIUMPH | NCT03413995 | HSPC | 2 | PSA-RR | R, no ADT given | Yes | 30 |
| PLATI-PARP | NCT03442556 | CRPC | 2 | rPFS | Carbo+D+R | Yes | 20 |
| {none} | NCT04253262 | CRPC | 1,2 | Safety | C+R | Yes (phase 2); No (phase 1) | 44 |
| {none} | NCT03572478 | CRPC or endometrial cancer | 1,2 | Safety, T-cell infilatration in tumor | N+R | No | 12 |
| {none} | NCT03840200 | CRPC, breast or ovarian cancer | 1,2 | Safety | I+R | No | 51 |
| RAMP | NCT04179396 | CRPC | 1 | PK of R | E+R vs E+A | No | 60 |
| Localized Prostate Cancer or PSA Relapse After Definitive Treatment | |||||||
| ROAR | NCT03533946 | HSPC | 2 | PSA-RR | R, no ADT given | Yes | 32 |
R= rucaparib; E= enzalutamide; D= docetaxel; A = abiraterone; I = Ipatasertib; C = copanlisib; N = nivolumab
PK = pharmacokinetics; PSA-RR = PSA response rate; rPFS = radiographic progression-free survival
*
Enrollment criteria varies for each biomarker selected trial for the allowed DNA alterations or other molecular criteria