ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:November 15, 2017
End Date:August 2020
Contact:Debbie Johnson
Email:debbie.johnson@constellationpharma.com
Phone:617-714-0555

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A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined With Enzalutamide or Abiraterone/Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

This is a two-arm, open label Phase 1b/2 study with an oral administration of CPI-1205 in
combination with either enzalutamide or abiraterone/prednisone in male patients with
metastatic Castration Resistant Prostate Cancer. This study is designed to determine the
maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety,
tolerability, pharmacokinetic, and efficacy profiles of CPI-1205 in combination with either
enzalutamide or abiraterone/prednisone.

Following determination of MTD and RP2D will proceed to phase 2. Patients in phase 2 will
receive CPI-1205 at the RP2D in combination with either enzalutamide or
abiraterone/prednisone vs either enzalutamide or abiraterone/prednisone as a control arm.


Inclusion Criteria:

- Adults (Age ≥ 18 years)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Life expectancy of at least 12 weeks

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Progressive disease in the setting of medical or surgical castration (i.e. CRPC)

- Documented metastatic disease

- Must have undergone bilateral orchiectomy (surgical castration) or be willing to
continue gonadotropin-releasing hormone (GnRH) analog or antagonist (medical
castration)

- Serum testosterone <50 ng/dL

- Receipt of prior line of second generation androgen inhibitor

- Demonstrate adequate organ function as defined below:

- Absolute Neutrophil Count (ANC) ≥ 1,000/μL

- Platelet Count ≥ 100,000/μL

- Hemoglobin (Hgb) ≥ 8 g/dL

- Serum creatinine ≤ 2 × upper limit of normal (ULN) OR

- Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft and Gault
formula1 in subjects with creatinine > 2 X ULN

- Bilirubin ≤ 1.5 × ULN unless evidence of Gilbert's disease in which case < 3 x
ULN

- Aspartate aminotransferase (AST) ≤ 2.5 × ULN without liver metastases; must be ≤
5 × ULN with liver metastases

- Alanine aminotransferase (ALT) ≤ 2.5 × ULN without liver metastases; must be ≤ 5
× ULN with liver metastases

Exclusion Criteria:

- Known symptomatic brain metastases (NOTE: patients with treated epidural disease are
allowed)

- Treatment with any of the following for prostate cancer within the indicated timeframe
prior to day 1 of treatment:

1. First generation: AR antagonists (e.g., bicalutamide, nilutamide, flutamide)
within 4 weeks

2. 5 alpha reductase inhibitors, ketoconazole, estrogens (including
diethylstilbesterol [DES]), or progesterones within 2 weeks

3. Chemotherapy within 3 weeks

4. Biologic therapy within 4 weeks

5. Investigational therapy within 3 weeks (or within a time interval less than at
least 5 half-lives of the investigational agent [if known], whichever is longer).

6. Immunotherapy within 4 weeks

7. Prior radionuclide therapy within 4 weeks
We found this trial at
33
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188 West Northern Lights Boulevard
Anchorage, Alaska 99503
Phone: 907-276-1455
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Albuquerque, New Mexico 87109
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Aurora, Colorado 80012
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Aurora, Colorado 80045
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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401 North Broadway
Baltimore, Maryland 21287
Phone: 410-955-4042
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8900 Wilshire Boulevard
Beverly Hills, California 90211
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-5701
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Bronx, New York 10469
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665 Elm Street
Buffalo, New York 14263
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Charlotte, North Carolina 28211
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Duarte, California 91010
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East Setauket, New York 11733
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520 Country Club Dr
Eugene, Oregon 97401
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Fort Worth, Texas 76104
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Gettysburg, Pennsylvania 17325
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Greenville, South Carolina 29605
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Hampton, Virginia 23666
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Indianapolis, Indiana 46202
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Jacksonville, Florida 32209
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
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Los Angeles, California 90095
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
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New York, New York 10029
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Omaha, Nebraska 68130
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Rockville, Maryland 20850
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Toledo, Ohio 43623
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