Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
mCRPC (Metastatic Castration-resistant Prostate Cancer) · Genital Diseases, Male · Urogenital Diseases, Male · Prostatic Disease · Prostatic Neoplasms, Castration-Resistant · Prostate Cancer
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 1/2
- Patients
- 54 (planned)
- Started
- Jan 1, 2024
- Main results expected
- Jan 2028
- Fully finished
- Jan 2030
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)
Measured over: Cycle 1, Day 1 to end of safety follow up (each cycle is 28 days and safety follow up will continue until 30 days after last dose of study medication)
Phase 1: Identification of the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPC
Measured over: Through Phase I completion, an average of 1 year.
Phase 2: Assessment of the antitumor activity of gedatolisib in combination with darolutamide in each arm as demonstrated by radiographic progression-free survival (rPFS) by arm
Measured over: 6 months
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT06190899 · record last updated 2026-04-13 · checked 2026-11-09 15:42 UTC