Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
Sarah Cannon
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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.
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.
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.
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.
You may not be 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.
Clareo Health | A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer
