Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02125084 | Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer | PHASE1 | COMPLETED | 38 | — | — | Oct 1, 2014 | May 3, 2021 | May 4, 2021 | 5 | United States |
MTD will be determined by testing increasing doses of everolimus with standard dose enzalutamide in 3-patient dose escalation cohorts. The MTD is defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (28 days) of therapy, assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
PSA response will be measured by the percent decreased from the reported baseline value. The proportion of patients with documented PSA decreases of 50% and 85% in PSA levels will be reported separately.
Evaluate the safety of the combination per CTCAE v4.0, every 4 weeks from date of first study treatment until the date of documented progression, up to 24 months.
Levels of everolimus in blood samples will be collected from patients at selected timepoints prior to dosing during the first 3 cycles of treatment.
| Arm | Type | Description |
|---|---|---|
| Everolimus and Enzalutamide | EXPERIMENTAL | Dose Escalation Phase (18 patients): 3-6 patients will be treated at each dose level until the Maximum Tolerated Dose (MTD) is determined. * Everolimus: Orally (PO) once daily (dose to be determined; * Enzalutamide: 160mg (four 40mg capsules) PO continuous daily dosing. Dose Expansion Phase (23 patients): Everolimus and Enzalutamide to be administered using the MTD determined in the dose escalation phase. |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | - |
| Enzalutamide | DRUG | - |
Inclusion Criteria: KEY POINTS: 1. Adenocarcinoma of the prostate confirmed histologically. 2. Metastatic disease confirmed by biopsy or imaging studies. 3. Castrate-resistant prostate cancer (i.e., progression of prostate cancer while receiving standard androgen ablation therapy, orchiectomy or l...