Phase 2
Completed N=142
A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer
Prostate Cancer Metastatic
Source: ClinicalTrials.gov NCT02407054 ↗
Enrolled (actual)
142
Serious AEs
21.1%
Results posted
May 2021
Primary outcomePrimary: Part B: Progression Free Survival (PFS) — 3.78; 2.83 months
Summary
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY3023414 in combination with enzalutamide in men with prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part B: Progression Free Survival (PFS) |
3.78; 2.83 | — |
| SECONDARY Part B: Time to Disease Progression (TTP) |
5.06; 3.61 | — |
| SECONDARY Part B: Percentage of Participants With Prostate Specific Antigen Response |
21.5; 25.0; 7.6; 9.3 | — |
| SECONDARY Part A: Pharmacokinetic (PK): Area Under the Concentration-time Curve Over the Dosing Interval (AUCτ) of LY3023414 |
3230; 1820 | — |
| SECONDARY Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
4.6; 4.6 | — |
Eligibility Criteria
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 radiographic progression according to prostate cancer working group 2 (PCWG2).
- Prior abiraterone treatment completed at least 4 weeks prior to cycle 1 day 1. Participants must have failed prior abiraterone treatment.
- Surgically or medically castrated, with testosterone levels of 480 milliseconds (ms) on screening electrocardiogram (ECG) per Friderica's formula, unstable angina, or myocardial infarction (MI) in 6 months prior to study drug administration.
- Clinically significant electrolyte imbalance ≥ grade 2.
- Currently receiving treatment with therapeutic doses of warfarin sodium.
- Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤28 days prior to day 1 of cycle 1.
- Concurrent serious infections requiring parenteral antibiotic therapy.
- Have a second primary malignancy that in the judgment of the investigator and medical monitor may affect the interpretation of results.
- Have an active, known fungal, bacterial, and/or known viral infection.
Data sourced from ClinicalTrials.gov (NCT02407054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.