Phase 2
Completed N=277
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Source: ClinicalTrials.gov NCT02952534 ↗Enrolled (actual)
277
Serious AEs
34.7%
Results posted
Jun 2022
Primary outcomePrimary: Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR) — 45.7; 0.0; 0.0; 0.0 percentage of participants
Summary
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR) |
45.7; 0.0; 0.0; 0.0; 41.2 | — |
| SECONDARY Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV) |
48.3; 9.5; 0.0; 25.0; 41.2 | — |
| SECONDARY Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR) |
15.5; 22.1 | — |
| SECONDARY Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator |
6.6; 7.5; 16.6; 18.4 | — |
| SECONDARY Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory |
53.5; 3.4; 7.1; 14.3; 36.0 | — |
| SECONDARY Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory |
19.8; 0; 0; 14.3; 16.0 | — |
| SECONDARY Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR) |
10.7; 5.3; 3.7; 9.4; 11.6 | — |
| SECONDARY Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator |
9.6; 7.8; 3.7; 3.5; 11.6 | — |
| SECONDARY Overall Survival (OS) by Gene |
17.2; 14.6; 13.9; 11.1; 11.6 | — |
| SECONDARY Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR) |
100; 10; 2; 2; 13; 36 | — |
| SECONDARY Clinical Benefit Rate (CBR) by Gene Per Investigator |
103; 17; 3; 2; 14; 39 | — |
| SECONDARY Time to PSA Progression by Gene |
6.5; 3.1; 3.5; 5.6; 5.3 | — |
| SECONDARY Steady State Trough (Cmin) Level Rucaparib Concentrations |
1539.565; 1605.002; 1639.357; 1286.998; 1189.845; 1578.353 | — |
Eligibility Criteria
Inclusion Criteria
- Be 18 years old at the time the informed consent form is signed
- Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate
- Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
- Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
- Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency
Exclusion Criteria
- Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib
Data sourced from ClinicalTrials.gov (NCT02952534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.