Study Comparing Orteronel Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01193244
First received: August 31, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)


Condition Intervention Phase
Prostate Cancer
Drug: Orteronel + prednisone
Drug: Placebo + prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Radiographic progression-free survival (rPFS) [ Time Frame: Day 1 to radiographic disease progression or death ] [ Designated as safety issue: No ]
    Time from randomization to radiographic disease progression or death from any cause, whichever occurs first

  • Overall survival (OS) [ Time Frame: Time from date of patient randomization to the date of patient death due to any cause ] [ Designated as safety issue: No ]
    Overall survival


Secondary Outcome Measures:
  • 50% prostate specific antigen (PSA) response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    50% PSA response at 12 weeks

  • Changes in circulating tumor cell (CTC) counts [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Favorable changes in CTC levels at 24 weeks

  • Time to pain progression [ Time Frame: From randomization to the end of treatment ] [ Designated as safety issue: No ]
    Time to pain progression as measured by worst pain item in the Brief Pain Inventory-Short Form (BPI-SF) and changes in opioid analgesic use, if any


Estimated Enrollment: 1454
Study Start Date: October 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orteronel + prednisone Drug: Orteronel + prednisone
Orteronel and prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of <50 ng/dL.
Placebo Comparator: Placebo + prednisone Drug: Placebo + prednisone
Placebo and prednisone will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of <50 ng/dL.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

  • Voluntary written consent
  • Male patients 18 years or older
  • Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
  • Radiograph-documented metastatic disease
  • Progressive disease
  • Prior surgical castration or concurrent use of an agent for medical castration
  • Either absence of pain or pain not requiring use of any opioid or narcotic analgesia in the 2 weeks prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Even if surgically sterilized, patients must practice effective barrier contraception during the entire study treatment and for 4 months after the last dose of study drug, OR abstain from heterosexual intercourse
  • Meet screening laboratory values as specified in protocol
  • Stable medical condition

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
  • Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
  • Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all others prior to first dose of study drug
  • Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days within 3 months prior to study
  • Received prior chemotherapy for prostate cancer with exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening
  • Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug; exposure to external beam radiation within 2 weeks of start of screening until receiving the first dose of study drug
  • Documented central nervous system metastases
  • Treatment with any investigational compound within 30 days prior to first dose of study drug
  • Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction
  • Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
  • Uncontrolled cardiovascular condition as specified in study protocol
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
  • Unwilling or unable to comply with protocol
  • Uncontrolled nausea, vomiting or diarrhea
  • Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193244

  Hide Study Locations
Locations
United States, Alaska
Anchorage, Alaska, United States, 99508
United States, Arizona
Tucson, Arizona, United States, 85710
United States, Arkansas
Fort Smith, Arkansas, United States, 72903
United States, California
Los Angeles, California, United States, 90025
San Diego, California, United States, 92120
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Boynton Beach, Florida, United States, 33426
Fort Myers, Florida, United States, 33916
Jacksonville, Florida, United States, 32224
Port Saint Lucie, Florida, United States, 34952
United States, Indiana
Indianapolis, Indiana, United States, 46219
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maryland
Westminster, Maryland, United States, 21157
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Columbia, Missouri, United States, 65201
Jefferson City, Missouri, United States, 65109
United States, Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Hackensack, New Jersey, United States
United States, New York
East Syracuse, New York, United States, 13057
New York, New York, United States
Rochester, New York, United States, 14623
United States, North Carolina
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Lancaster, Pennsylvania, United States, 17604
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston, South Carolina, United States, 29425
Columbia, South Carolina, United States, 29102
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Nashville, Tennessee, United States, 37203
United States, Texas
Amarillo, Texas, United States, 79106
Bedford, Texas, United States, 76022
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75231
Denton, Texas, United States, 76210
Midland, Texas, United States, 79701
Odessa, Texas, United States, 79761
Tyler, Texas, United States, 75702
United States, Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Newport News, Virginia, United States, 23606
Norfolk, Virginia, United States, 23502
Australia, Queensland
Redcliffe, Queensland, Australia
Australia, Tasmania
Hobart, Tasmania, Australia
Australia, Victoria
Wodonga, Victoria, Australia
Belgium
Edegem, Belgium
Hasselt, Belgium
Kortrijk, Belgium
Leuven, Belgium
Namur, Belgium
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y2H4
Surrey, British Columbia, Canada, V3V1N1
Canada, Ontario
Brampton, Ontario, Canada, L6T4S5
Burlington, Ontario, Canada, L7N3V2
Burlington, Ontario, Canada, L7S1V2
Guelph, Ontario, Canada, N1H5J1
Hamilton, Ontario, Canada, L8N4A6
London, Ontario, Canada
Newmarket, Ontario, Canada
Ottawa, Ontario, Canada, K1H1A2
Owen Sound, Ontario, Canada, N4K2J1
Scarborough, Ontario, Canada, M1P2T7
Toronto, Ontario, Canada
Toronto, Ontario, Canada, M1W-4V5
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V2H3
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada, H9R4S3
Sherbrooke, Quebec, Canada
Czech Republic
Dromenz, Czech Republic
Hradec, Czech Republic
Modrive, Czech Republic
Praha, Czech Republic
Zlin, Czech Republic
Estonia
Tallinn, Estonia
Finland
Seinajoki, Finland
Tampere, Finland
France
La Roche-sur-Yon, France
Lyon, France
Lyon Cedex, France
Marseille, France
Paris, France
Poitiers, France
Villejuif cedex, France, 94805
Greece
Patras, Greece
Hungary
Budapest, Becsi, Hungary, ut61
Casabai kapu, Hungary
Miskolc, Hungary
Munkacsy Mihaly, Hungary
Osztaly, Hungary
Italy
Novara, Italy
Rome, Italy
Latvia
Daugavpils, Latvia
Lieaja, Latvia
Riga, Latvia
Netherlands
Eindhoven, Netherlands
TweeSteden ziekenhuis, Netherlands
New Zealand
Christchurch, New Zealand
Poland
Bielsko-Biala, Poland
Goczalkowice Zdroj, Poland
Warsaw, Poland
Wroclaw, Poland
Singapore
Singapore, Singapore, 169610
Slovakia
Nitra, Slovakia
Presov, Slovakia
Tenicin, Slovakia
Trencin, Slovakia
Turkey
Ankara, Turkey, 06500
Balcali, Turkey
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01193244     History of Changes
Other Study ID Numbers: C21004, 2010-018661-35
Study First Received: August 31, 2010
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014