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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02407054 | A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer | PHASE2 | COMPLETED | 142 | — | — | Apr 29, 2015 | Apr 16, 2020 | May 11, 2021 | 36 | United States |
PFS was defined as the time from randomization until the date of clinical (symptomatic or radiographic) and/or prostate specific antigen (PSA) disease progression per Prostate Cancer Clinical Trials Working Group (PCWG2) or death by any cause regardless of whether the participants withdraws from study drug or receives a subsequent anti-cancer therapy (as determined by the investigator). Participants who have not progressed or died at the time of assessment were censored at the time of the last date of assessment (tumor evaluation or PSA level).
| Arm | Type | Description |
|---|---|---|
| Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QD | EXPERIMENTAL | Participants received 200 milligrams (mg) LY3023414 orally twice daily (BID) during the initial week to assess pharmacokinetics (PK). Thereafter, participants received 200 mg of LY3023414 BID in combination with 160 mg of enzalutamide QD beginning Cycle 1 Day 1. A treatment cycle was defined as 28 days. |
| Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QD | EXPERIMENTAL | Participants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD). |
| Part B: Placebo + 160 mg Enzalutamide QD | ACTIVE_COMPARATOR | Participants received placebo in combination with 160 mg enzalutamide QD. |
| Name | Type | Description |
|---|---|---|
| LY3023414 | DRUG | Administered orally |
| Enzalutamide | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate. * Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan. * Prostate cancer progression documented by PSA and/or ra...