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Prostate Cancer MetastaticPhase 2NCT02407054

A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer

A Phase 2 study testing LY3023414 and Enzalutamide in people with Prostate Cancer Metastatic, run by Eli Lilly and Company at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
LY3023414 and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
36 sitesUnited States
Study dates
29 Apr 2015to 16 Apr 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Fort Wayne Oncology & Hematology

    Fort Wayne, Indiana, 46845

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Fort Worth, Texas, 76104

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Urology Centers of Alabama, P.C.

    Homewood, Alabama, 35209

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Indiana Cancer Pavilion

    Indianapolis, Indiana, 46202-5286

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania, 17604

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Prostate Oncology Specialists

    Marina del Rey, California, 90292

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minnesota Oncology/Hematology PA

    Minneapolis, Minnesota, 55404

  • Garden State Urology

    Morristown, New Jersey, 07960

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Urology Associates

    Nashville, Tennessee, 37209

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Urology Cancer Center

    Omaha, Nebraska, 68130

  • Univ of Pittsburgh Cancer Inst. (UPCI)

    Pittsburgh, Pennsylvania, 15213

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Florida Cancer Specialists North

    St. Petersburg, Florida, 33705

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

  • US Oncology

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialists PC

    Tualatin, Oregon, 97062

  • Delaware Valley Urology

    Voorhees Township, New Jersey, 08043

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Double-Blinded, Placebo-Controlled, Randomized Phase II Study of Enzalutamide With or Without the PI3 Kinase/mTOR Inhibitor LY3023414 in Men With Metastatic Castration Resistant Prostate Cancer

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.

Being tested
LY3023414, Enzalutamide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3023414Drug

    Administered orally

  • EnzalutamideDrug

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT02407054
Study groupRoleWhat they receive
Part A: 200 mg LY3023414 BID + 160 mg of Enzalutamide QDExperimentalParticipants 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.
Receives: Drug: LY3023414; Drug: Enzalutamide
Part B: 200 mg LY3023414 BID + 160 mg Enzalutamide QDExperimentalParticipants received 200 mg LY3023414 orally BID in combination with 160 mg enzalutamide orally once daily (QD).
Receives: Drug: LY3023414; Drug: Enzalutamide
Part B: Placebo + 160 mg Enzalutamide QDActive comparatorParticipants received placebo in combination with 160 mg enzalutamide QD.
Receives: Drug: Enzalutamide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part B: Progression Free Survival (PFS)

    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).

    Measured: Randomization to Measured Progressive Disease or Death from Any Cause (Up To 34 Months)

Secondary outcomes (4)

  1. Part B: Time to Disease Progression (TTP)

    TTP was defined as 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).

    Measured: Randomization to Objective Disease Progression (Up To 34 Months)

  2. Part B: Percentage of Participants With Prostate Specific Antigen Response

    PSA response was defined as more than 50% and 90% reduction from baseline to lowest post baseline value. 95% Confidence Intervals are based on Fisher's Exact Method.

    Measured: 12 Weeks

  3. Part A: Pharmacokinetic (PK): Area Under the Concentration-time Curve Over the Dosing Interval (AUCτ) of LY3023414

    PK: Area under the Concentration-time Curve Over the Dosing Interval (AUCτ) of LY3023414

    Time Frame:

    Part A LY3023414 200 mg: Day-1 pre-dose, 1.5, 3, and 6 hours post LY3023414 dose, Cycle 1 Day 1 pre-dose of LY3023414 and enzalutamide, and Part A Day 15 Pre-dose of LY3023414 and enzalutamide 1.5, 3, and 6 hours post LY3023414 dose;

    Measured: Part A: 200 mg LY3023414 + 160 mg Enzalutamide: Cycle 1 Day 15 Pre-dose of LY3023414 and enzalutamide 1.5, 3, and 6 hours post LY3023414 dose

  4. Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

    ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: Randomization to Second Measured Complete Response or Partial Response (Up To 34 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study start29 Apr 2015
  3. Primary completion26 Sep 2018
  4. Study completion16 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407054
Sponsor's protocol ID
15798
Other IDs
I6A-MC-CBBD
Status last verified
Jun 2020
First submitted
30 Mar 2015
Last updated
11 May 2021
Data monitoring committee
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Sweeney CJ, Percent IJ, Babu S, Cultrera JL, Mehlhaff BA, Goodman OB, Morris DS, Schnadig ID, Albany C, Shore ND, Sieber PR, Guba SC, Zhang W, Wacheck V, Donoho GP, Szpurka AM, Callies S, Lin BK, Bendell JC. Phase Ib/II Study of Enzalutamide with Samotolisib (LY3023414) or Placebo in Patients with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2022 Jun 1;28(11):2237-2247. doi: 10.1158/1078-0432.CCR-21-2326.

    PubMed 35363301

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3023414 and Enzalutamide in people with Prostate Cancer Metastatic, run by Eli Lilly and Company at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part B: Progression Free Survival (PFS) (time frame: Randomization to Measured Progressive Disease or Death from Any Cause (Up To 34 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02407054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.

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