TRITON2
TRITON2: rucaparib in metastatic castration-resistant prostate cancer associated with homologous recombination deficiency
Phase 2N = 115NCT02952534
- Population
- Efficacy and safety populations: 115 men with a deleterious BRCA1 or BRCA2 alteration who progressed after one to two lines of next-generation androgen receptor-directed therapy and one taxane-based chemotherapy for mCRPC and received at least one dose of rucaparib
- Design
- International, open-label phase 2 study of rucaparib 600 mg twice daily with a single treatment group (fully enrolled and ongoing at the time of the report). The study's primary endpoint was objective response rate by blinded independent radiology review (RECIST/PCWG3, patients with measurable disease), supported by investigator-assessed ORR; locally assessed PSA response (a fall of at least 50% from baseline) was also a key efficacy endpoint.
- Arms
- Rucaparib (experimental, n = 115): Rucaparib 600 mg orally twice daily
- People
- Abida W
Show the numbers
| Endpoint | Analysis | Rucaparib | Control | Effect |
|---|---|---|---|---|
| ORRPatients with a BRCA alteration and measurable disease, independent radiology review (27 of 62)Confirmed objective response rate | primaryAbida 2020 | 43.5% (31.0–56.7%) | — | Confirmed objective response rate; the study's primary endpoint (independent radiology review, IRR-evaluable population); single-arm study. |
| ORRPatients with a BRCA alteration and measurable disease, investigator assessment (33 of 65)Confirmed objective response rate | primaryAbida 2020 | 50.8% (38.1–63.4%) | — | Confirmed objective response rate by investigator assessment; supporting endpoint to the independent-review ORR (the label 'primary' marks a key efficacy analysis); single-arm study. |
| PSA response ratePatients with a BRCA alteration, with or without measurable disease (63 of 115)PSA reduction of at least 50% from baseline | primaryAbida 2020 | 54.8% (45.2–64.1%) | — | Confirmed PSA response rate (fall of at least 50% from baseline, locally assessed); a key efficacy endpoint, not the study's primary endpoint (the label 'primary' marks a key efficacy analysis); single-arm study. |
| Endpoint | Analysis | Rucaparib | Control | Effect |
|---|---|---|---|---|
| ORRPatients with a BRCA alteration and measurable disease, independent radiology review (27 of 62)Confirmed objective response rate | primaryAbida 2020 | 43.5% (31.0–56.7%) | — | Confirmed objective response rate; the study's primary endpoint (independent radiology review, IRR-evaluable population); single-arm study. |
| ORRPatients with a BRCA alteration and measurable disease, investigator assessment (33 of 65)Confirmed objective response rate | primaryAbida 2020 | 50.8% (38.1–63.4%) | — | Confirmed objective response rate by investigator assessment; supporting endpoint to the independent-review ORR (the label 'primary' marks a key efficacy analysis); single-arm study. |
| PSA response ratePatients with a BRCA alteration, with or without measurable disease (63 of 115)PSA reduction of at least 50% from baseline | primaryAbida 2020 | 54.8% (45.2–64.1%) | — | Confirmed PSA response rate (fall of at least 50% from baseline, locally assessed); a key efficacy endpoint, not the study's primary endpoint (the label 'primary' marks a key efficacy analysis); single-arm study. |