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PFEPfizerRunning, no new patients

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

mCRPC

0Calmworry score, out of 100

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

No changes since Tremor started watching this trial.
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

See the official record on ClinicalTrials.gov (NCT03395197) ↗