Gedatolisib and Darolutamide for Metastatic Prostate Cancer
This study is testing a combination of two drugs, gedatolisib and darolutamide, for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to standard hormone therapy. Gedatolisib works by targeting specific pathways (PI3K and mTOR) that can help cancer grow, while darolutamide is a drug that blocks male hormones. The study aims to find the safest and most effective dose of these drugs together (Phase 1) and then see how well they shrink tumors or slow their growth (Phase 2). You may be eligible if you are an adult male with mCRPC that has progressed after other hormone treatments. The study is currently recruiting about 54 participants.
- Study design
- This is a Phase 1/2, open-label, randomized study designed to find the right dose and then evaluate the effectiveness of gedatolisib in combination with darolutamide. It plans to enroll 54 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be followed until 30 days after the last dose of study medication. Tumor response will be assessed at 6 months in Phase 2.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
At a glance
Conditions
Where it's being run
13 sites across 4 statesStudy leadership
- Nadene Zack, MS · STUDY_DIRECTOR · Celcuity Inc
Who to contact
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What this trial measures
- Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)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)
Type, incidence, severity (as graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities
- Phase 1: Identification of the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPCThrough Phase I completion, an average of 1 year.
Incidence of dose-limiting toxicities (DLTs) and AEs graded according to NCI CTCAE v5.0
- 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 arm6 months
Radiographic progression-free survival rate at 6 months as measured by the Kaplan-Meier (K-M) method and assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria