A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:April 29, 2015
End Date:November 1, 2019

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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.


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 < 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.

Exclusion Criteria:

- 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.
We found this trial at
36
sites
3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Ivor J. Percent
Phone: 239-274-9930
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Christopher J Sweeney
Phone: 617-632-5869
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Robert Dreicer
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: David Waterhouse
Phone: 513-891-4800
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Jorge Garcia
Phone: 21644468933
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Dallas, Texas 75390
Principal Investigator: Kevin Courtney
Phone: 214-645-8787
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Daniel G Chong
Phone: 703-280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fayetteville, Arkansas 72703
Principal Investigator: Joseph T Beck
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Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 260-969-7864
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1450 8th Avenue
Fort Worth, Texas 76104
Principal Investigator: Stephen L Richey
Phone: 817-850-2174
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Principal Investigator: Mark F Kozloff
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Homewood, Alabama 35209
Principal Investigator: Mark S Deguenther
Phone: 205-445-0125
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Houston, Texas 77024
Principal Investigator: Gurjyot K Doshi
Phone: 713-467-1722
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Indianapolis, Indiana 46202
Principal Investigator: Nabil Adra
Phone: 317-948-6942
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Lancaster, Pennsylvania 17601
Principal Investigator: Paul R. Sieber
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Oscar B Goodman
Phone: 702-952-1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Marina Del Rey, California 90292
Principal Investigator: Mark C Scholz
Phone: 310-827-7707
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Kathryn Bylow
Phone: 414-805-8843
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55405
Principal Investigator: Samith T Kochuparambil
Phone: 612-884-6300
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Morristown, New Jersey 07960
Principal Investigator: Adam J Berman
Phone: 973-539-1050
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Principal Investigator: Neal Shore
Phone: 843-449-1010
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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Nashville, Tennessee 37209
Principal Investigator: David S Morris
Phone: 615-250-9265
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Chock Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 877-691-7274
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Principal Investigator: Mark T Fleming
Phone: 757-466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Omaha, Nebraska 68130
Principal Investigator: Luke Nordquist
Phone: 402-991-8468
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Leonard Appleman
Phone: 412-692-4724
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Principal Investigator: Jennifer L Cultrera
Phone: 727-216-1143
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7901 Frost Street
San Diego, California 92123
858-939-3400
Principal Investigator: Charles Redfern
Phone: 858-939-5062
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Song Q Zhao
Phone: 206-215-2243
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Springfield, Oregon 97477
Principal Investigator: Bryan A Mehlhaff
Phone: 541-284-5508
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Syracuse, New York 13210
Principal Investigator: Christopher Pieczonka
Phone: 315-478-4185
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The Woodlands, Texas 77380
Principal Investigator: SMO US Oncology
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Tualatin, Oregon 97062
Principal Investigator: Ian Denison Schnadig
Phone: 503-885-5411
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Voorhees, New Jersey 08043
Principal Investigator: Gordon Brown
Phone: 856-673-1600
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West Palm Beach, Florida 33401
Principal Investigator: Avram Smukler
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