Metastasic Castration-Resistant Prostate Cancer (mCRPC)
Conditions
Brief summary
Phase 1: 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: BOIN utility score, which includes pre-defined toxicity criteria and 6-month radiographic progression-free survival (rPFS) binary outcomes, Phase 1: Incidence of dose-limiting toxicities (DLTs) and AEs graded according to NCI CTCAE v5.0, Phase 2: rPFS 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
Detailed description
Phase 1: Gedatolisib maximum observed concentration (Cmax), area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24; Cycle 2 only), and area under the plasma concentration-time curve from 0 to last measurable concentration (AUC0-t), Phase 2: rPFS rates at 9 and 12 months and overall rPFS, Phase 2: Overall response rate (ORR): percentage of subjects who achieved an objective response (OR) based on RECIST v1.1 with modifications as specified in PCWG3 criteria for all efficacy endpoints (complete response [CR] or partial response [PR]), Phase 2: Duration of response (DOR): time from the assessment of initial response (PR or better) to death or first documented disease progression, whichever occurs first, Phase 2: Clinical benefit rate (CBR): percentage of subjects with CR, PR, or stable disease (SD) ≥24 weeks, Phase 2: Disease control rate (DCR): percentage of subjects with CR, PR, or SD, Phase 2: Overall Survival (OS) rate at 18 and 24 months, Phase 2: Type, incidence, severity (as graded by NCI CTCAE v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities, Phase 2: PK parameters to be estimated by population PK analysis
Interventions
Sponsors
Celcuity Inc.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: 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: BOIN utility score, which includes pre-defined toxicity criteria and 6-month radiographic progression-free survival (rPFS) binary outcomes, Phase 1: Incidence of dose-limiting toxicities (DLTs) and AEs graded according to NCI CTCAE v5.0, Phase 2: rPFS 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: Gedatolisib maximum observed concentration (Cmax), area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24; Cycle 2 only), and area under the plasma concentration-time curve from 0 to last measurable concentration (AUC0-t), Phase 2: rPFS rates at 9 and 12 months and overall rPFS, Phase 2: Overall response rate (ORR): percentage of subjects who achieved an objective response (OR) based on RECIST v1.1 with modifications as specified in PCWG3 criteria for all efficacy endpoints (complete response [CR] or partial response [PR]), Phase 2: Duration of response (DOR): time from the assessment of initial response (PR or better) to death or first documented disease progression, whichever occurs first, Phase 2: Clinical benefit rate (CBR): percentage of subjects with CR, PR, or stable disease (SD) ≥24 weeks, Phase 2: Disease control rate (DCR): percentage of subjects with CR, PR, or SD, Phase 2: Overall Survival (OS) rate at 18 and 24 months, Phase 2: Type, incid | — |
Countries
France, Spain
Outcome results
None listed