A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer Metastatic

In brief

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.

Key facts

Study ID

NCT02407054

Run by

Eli Lilly and Company

People needed

142

Starts

2015-04-29

Expected to finish

2020-04-16

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 50 nanograms/deciliter.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Ability to swallow the study drugs whole.
• Adequate hematologic function.
• Adequate coagulation parameters, defined as international normalization ratio (INR) ≤ 2.
• Availability of tumor tissue from any time since diagnosis of prostate cancer disease. If no tumor samples are available the participant might still be eligible following discussion between the investigator and the medical monitor.

You may not qualify if…

• Prior cytotoxic chemotherapy, immunotherapy, a PI3K/AKT/mTOR agent (including TORC1 and TORC2 inhibitors), or RA 223 dichloride for the treatment of castration resistant prostate cancer (CRPC). Participants may have received docetaxel in the hormone-sensitive setting.
• Prior investigational new generation potent anti-androgen therapy (such as ARN 509).
• Prior treatment with enzalutamide.
• Pathological finding consistent with small cell carcinoma of the prostate.
• Prior systemic treatment with an azole drug (fluconazole, itraconazole) within 4 weeks of cycle 1 day 1.
• Known brain metastasis.
• History of (a) seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma); (b) loss of consciousness or transient ischemic attack within 12 months prior to day 1 of cycle 1.
• Uncontrolled hypertension (systolic blood pressure [BP] ≥ 160 millimeters of mercury [mmHg] or diastolic BP ≥ 95 mmHg).
• Have serious pre-existing medical conditions (at the discretion of the investigator).
• Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
• Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c <7%.
• Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade ≥2 diarrhea, and malabsorption syndrome).
• Have a history of New York Heart Association (NYHA) Class ≥3, QTc interval > 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.

Where it is running

• Urology Centers of Alabama, P.C. — Homewood, Alabama, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Prostate Oncology Specialists — Marina del Rey, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists North — St. Petersburg, Florida, United States
• Florida Cancer Specialists East — West Palm Beach, Florida, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Fort Wayne Oncology & Hematology — Fort Wayne, Indiana, United States
• Indiana Cancer Pavilion — Indianapolis, Indiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Minnesota Oncology/Hematology PA — Minneapolis, Minnesota, United States
• Urology Cancer Center — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Garden State Urology — Morristown, New Jersey, United States
• Delaware Valley Urology — Voorhees Township, New Jersey, United States
• Associated Medical Professionals of NY — Syracuse, New York, United States
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Urology Institute — Springfield, Oregon, United States
• Northwest Cancer Specialists PC — Tualatin, Oregon, United States
• Urological Associates of Lancaster — Lancaster, Pennsylvania, United States
• Univ of Pittsburgh Cancer Inst. (UPCI) — Pittsburgh, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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