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

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ClinicalTrials.gov Identifier: NCT03480646
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Constellation Pharmaceuticals

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer (mCRPC) Drug: CPI-1205 Drug: Enzalutamide Drug: Abiraterone/Prednisone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPI-1205 Combination with Enzalutamide Drug: CPI-1205
Administered orally

Drug: Enzalutamide
Administered orally

Experimental: CPI-1205 Combination with Abiraterone/Prednisone Drug: CPI-1205
Administered orally

Drug: Abiraterone/Prednisone
Administered orally




Primary Outcome Measures :
  1. Frequency of Dose-limiting toxicities (DLTs) [ Time Frame: 1 year ]
    The RP2D will be selected based on PK and the overall tolerability of each of the combinations (i.e with either enzalutamide or abiraterone/prednisone), but will not exceed the MTD.


Secondary Outcome Measures :
  1. PSA50 [ Time Frame: 1 year ]
    The proportion of patients with a ≥50% reduction in PSA from baseline.

  2. CTC [ Time Frame: 1 year ]
    In patients who enter the trial with unfavorable CTCs (five or more cells per 7.5mL of blood), conversion to favorable status is defined as four or fewer cells per 7.5 mL of blood. The CTC conversion rate is the proportion of patients who convert to favorable status.

  3. CTC 30% Response Rate [ Time Frame: 1 year ]
    CTC 30% response is defined as a ≥30% reduction in CTCs from baseline in patients who enter the trial with unfavorable CTCs

  4. Objective response rate [ Time Frame: 1 year ]
    The proportion of patients with a CR or PR per PCWG3.

  5. Time to PSA progression [ Time Frame: 1 year ]
  6. Radiographic progression free survival [ Time Frame: 1 year ]
  7. Time to first skeletal-related event (SRE) [ Time Frame: 1 year ]
  8. Time to first symptomatic skeletal event (SSE) [ Time Frame: 1 year ]
  9. Time to clinical progression [ Time Frame: 1 year ]
  10. Time to initiation of new systemic treatment for prostate cancer [ Time Frame: 1 year ]
  11. To further evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability) [ Time Frame: 1 year ]
    Adverse Events

  12. Pharmacokinetic parameters [ Time Frame: 1 year ]
    Area under the concentration versus time curves (AUC)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480646


Contacts
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Contact: Debbie Johnson 617-714-0555 debbie.johnson@constellationpharma.com
Contact: Latasha Nisbett Latasha.Nisbett@constellationpharmaceuticals.com

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Locations
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United States, Alaska
Alaska Urological Institute Recruiting
Anchorage, Alaska, United States, 99503
Contact: Talia Wyckoff       twyckoff@akmed.com   
United States, California
Beverly Hills Cancer Center (BHCC) Recruiting
Beverly Hills, California, United States, 90211
Contact: Myo Zaw       mzaw@bhcancercenter.com   
John Wayne Cancer Inst. Recruiting
Duarte, California, United States, 91010
Contact: Lisa Van Kreuningen       lvk@jwci.org   
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Jae Young Kwak       jkkwak@mednet.ucla.edu   
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Aurora, Colorado, United States, 80045
Contact: Patrick Ssebikejje       patrick.ssebikejje@usoncology.com   
University of Colorado Hospital - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Moli Keeler    720-848-9383    Molika.keeler@ucdenver.edu   
United States, Florida
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Contact: Tina Bottini       tina.bottini@jax.ufl.edu   
Mount Sinai Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33140
Contact: Yvonne Enriquez-Nunez       yenrique@msmc.com   
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Caitlin Grainger       Caitlin.Grainger@moffitt.org   
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Pam Sroka       pamela_sroka@rush.edu   
University of Illinois Hospital and Health Systems Recruiting
Chicago, Illinois, United States, 60612
Contact: Leopoldo Castillo       leoca@uic.edu   
United States, Indiana
Indiana University- Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sheri Lipps       sheri.lipps@ecommunity.com   
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Gaynelle Davis       gdavis7@tulane.edu   
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Michele Besche       mbesche@umm.edu   
John Hopkins Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Rehab AbdAllah       rabdall1@jhmi.edu   
Maryland Oncology Hematology Recruiting
Rockville, Maryland, United States, 20850
Contact: Cathleen Ganley       cathleen.ganley@usoncology.com   
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Meredith Sleeper       meredithf_sleeper@dfci.harvard.edu   
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Stephanie Mintoff       smintof1@hfhs.org   
United States, Nebraska
GU Research Network Recruiting
Omaha, Nebraska, United States, 68130
Contact: Erin Powers       epowers@gucancer.com   
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Christina Shirley       Christina.Shirley@usoncology.com   
United States, New Mexico
New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Evan Harris       ErHarris@salud.unm.edu   
United States, New York
Eastchester Center for Cancer Care Recruiting
Bronx, New York, United States, 10469
Contact: Carmen Vicuna       cvicuna@nycancer.com   
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Contact: Ann Marie DiRaddo       AnnMarie.DiRaddo@RoswellPark.org   
North Shore Hematology Oncology Associates Recruiting
East Setauket, New York, United States, 11733
Contact: Stephen Pentheros       spentheros@nycancer.com   
NYU Langone Medical Center Laura and Isaac Permlutter Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Denueve Shepherd       denueve.shepherd@nyumc.org   
Icahn School of Medicine at Mt. Sinai Recruiting
New York, New York, United States, 10029
Contact: Mahalya Gogerly-Moragoda       anisha.gogerly-moragoda@mssm.edu   
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Bryan Cox       bryan_cox@med.unc.edu   
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Heather Neagle       Heather.Neagle@atriumhealth.org   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 22710
Contact: Christine Daly       Christine.daly@duke.edu   
United States, Ohio
Ohio State University - James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Zachary Polcyn       Zachary.Polcyn@osumc.edu   
Toledo Clinic Cancer Center Recruiting
Toledo, Ohio, United States, 43623
Contact: Jennifer Martinez       jmartinez@toledoclinic.com   
United States, Oregon
Williamette Valley Cancer Institute and Research Center Recruiting
Eugene, Oregon, United States, 97401
Contact: Jeanne Schaffer       jeanne.schaffer@usoncology.com   
Compass Oncology - East Recruiting
Tualatin, Oregon, United States, 97062
Contact: Julian Kern       Julian.Kern@compassoncology.com   
United States, Pennsylvania
St. Luke's University Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Elana Pessin       elana.pessin@sluhn.org   
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17331
Contact: Vanessa Warner       vwarner@gettysburgoncology.com   
United States, South Carolina
Greenville Hospital System, Institute for Translational Oncology Research Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jan Kueber       jkueber@ghs.org   
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Rebecca Floyd       rfloyd@curcmb.com   
United States, Texas
Texas Oncology - Central Austin Cancer Center Recruiting
Austin, Texas, United States, 78731
Contact: Prexy Modi       prexy.modi@usoncology.com   
Texas Oncology- Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Nori Sullivan       nori.sullivan@usoncology.com   
Texas Oncology- Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Shelly Maxfield       shelly.maxfield@usoncology.com   
United States, Virginia
Virginia Oncology Associates Recruiting
Hampton, Virginia, United States, 23666
Contact: Karen McClain       karen.mcclain@usoncology.com   
Sponsors and Collaborators
Constellation Pharmaceuticals
Investigators
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Study Director: Debbie Johnson Constellation Pharmaceuticals

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Responsible Party: Constellation Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03480646     History of Changes
Other Study ID Numbers: 1205-201
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Constellation Pharmaceuticals:
Phase 1/2
Oncology
EZH2 Inhibitor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
(R)-N-((4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl)-2-methyl-1-(1-(1-(2,2,2-trifluoroethyl)piperidin-4-yl)ethyl)-1H-indole-3-carboxamide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action