Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 3
- Patients
- 1,054 (final count)
- Started
- Dec 18, 2017
- Main results expected
- Oct 3, 2022
- Fully finished
- Jun 30, 2027
- Results posted
- Jan 17, 2024
What counts as success
The trial's main goal(s), called the “primary outcome.”
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Measured over: Post dose on Day 1 up to Day 66 in Part 1
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Measured over: Post dose on Day 1 up to Day 66 in Part 1
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Measured over: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Measured over: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Measured over: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Measured over: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
Measured over: From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
Measured over: From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT03395197 · record last updated 2026-11-05 · checked 2026-11-09 15:36 UTC