LILLY GU115

Study StatusEnrolling
ProtocolGU115
SponsorEli Lilly
Study Description

A Phase 2 Randomized, Placebo-controlled Double-blind Study of Enzlutamide with or without the P13 Kinase/mTOR Inhibitor LY3023414 in men  with Metastatic Castration-resistant Prostate Cancer

Primary Endpoint

Compare progression-free survival (PFS) – PSA, radiographic or Prostate Cancer Clinical Trials Working Group (PCWG2) symptomatic progression – in men with mCRPC who are receiving enzalutamide plus LY3023414 versus enzalutamide plus placebo using PCWG2 criteria

Inclusion Criteria

-Subject must be a man age ≥ 18 years of age
-Adenocarcinoma of the prostate
-Metastatic disease as documented by bone scan or metastatic lesions by CT or MRI. If lymph node is only evidence of metastasis, it must be ≥ 2 cm in longest diameter
-Prostate cancer progression documented by PSA and/or radiographic progression according to PCWG2
-Prior abiraterone treatment completed at least 2 weeks prior to Cycle 1 Day 1
-If the patient has previously been treated with RA-223 dichloride, treatment must be completed at least 4 weeks prior to Cycle 1 Day1 (min. 4wk washout period)
-If patient was treated with abiraterone but their last treatment prior to enrolment was an anti-androgen other than abiraterone, PSA or symptomatic progression will need to be documented. The minimum washout period for these agents is as follows:

  • 6 wks for long acting agents
  • 4 wks for short acting agents
  • (Patients whose PSA did not decline for 3 or more months in response to an anti-androgen given as a second line or later intervention will require only a 2wk washout prior to Cycle1 Day1

-Surgically or medically castrated, with testosterone levels of < 50 ng/dL. If the subject is being treated with LHRH agonist (patients who have not undergone orchiectomy), this therapy must be continued throughout the study
-ECOG PS grade of 0 or 1
-Adequate hematologic function defined as:

  • ANC ≥1500/µL
  • Platelets ≥10,000/µL
  • Hgb ≥8g/dL

-Adequate liver function defined as:

  • ALT and AST ≤2.5 times the upper limit of normal (ULN). If the liver has tumor involvement AST and ALT equaling ≤5 times ULN is acceptable.
  • Total bilirubin ≤1.5 times ULN

-Adequate renal function defined as: Creatinine ≤1.5 times ULN or Creatinine Clearance >45 mL/min Cockcroft-Gault formula for patient with serum creatinine >1.5 time ULN
-Adequate coagulation parameters defined as INR ≤2
-Agrees to use a condom if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant during and 3 months after the last study drug administration. Must also agree not to donate sperm during the study

Exclusion Criteria

-Small cell carcinoma of the prostate
-Known brain metastases
-Prior cytotoxic chemotherapy for CRPC except docetaxel if administered in the hormone-sensitive setting. (a) P13/AKT/mTOR agent; (b) Immune checkpoint inhibitors; (c) Prior investigational new generation potent anti-androgen therapy e.g. ARN 509; (d) Prior treatment with enzalutamide
-Prior systemic treatment with an azole drug (fluconazole, itraconazole) within 4 weeks of Cycle1 Day1
-History of seizure or any condition that may predispose to seizure, loss of consciousness or transient ischemic attack within 12 months prior to Cycle1 Day1
- Uncontrolled HTN (SBP ≥ 160 mmHG or DBP ≥ 95)
-Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results (in the judgment of the investigator or sponsor)
-Have insulin-dependent diabetes, presence of active GI disease affecting absorption
- History of NYHA Class ≥3, QTc interval >450 ms on screening ECG per Friderica’s formula at several consecutive days of assessment, unstable angina, or MI in 6 months prior to study drug administration.
-Clinically significant electrolyte imbalance ≥Grade 2
-Receiving treatment with therapeutic doses of warfarin sodium
-Have initiated treatment with bisphosphonates or approved RANK ligand targeted agents ≤28 days prior to Cycle1 Day1
-Concurrent serious infections requiring parenteral antibiotic therapy.
-Second primary malignancy that may affect the interpretation of results (in the judgment of the investigator and medical monitor)
-Have an active, known fungal, bacterial, and/or known viral infection including: HIV, Hep A, B or C

Side Effects

Interested in enrolling in this trial? Please call 717-431-2285.


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