Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
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
5 other identifiers
interventional
1,560
38 countries
232
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Oct 2010
Typical duration for phase_3 prostate-cancer
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2016
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedMay 17, 2017
April 1, 2017
3.3 years
August 31, 2010
April 7, 2017
April 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Radiographic Progression-free Survival (rPFS)
rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.
Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)
Overall Survival
Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.
Baseline until death (up to 4.7 years)
Secondary Outcomes (21)
Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12
Week 12
Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12
Week 12
Time to Pain Progression
Baseline until End of treatment (EOT) (approximately up to 4.7 years)
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3
Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)
- +16 more secondary outcomes
Study Arms (2)
Orteronel + prednisone
EXPERIMENTALPlacebo + prednisone
PLACEBO COMPARATORInterventions
Orteronel 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 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (240)
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Anchorage, Alaska, United States
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Tucson, Arizona, United States
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Duarte, California, United States
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Highland, California, United States
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Orange, California, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Jeffersonville, Indiana, United States
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Kansas City, Kansas, United States
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Lansing, Michigan, United States
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Duluth, Minnesota, United States
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Corinth, Mississippi, United States
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Columbia, Missouri, United States
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Jefferson City, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Hackensack, New Jersey, United States
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East Syracuse, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Kettering, Ohio, United States
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Tualatin, Oregon, United States
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Hershey, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Piitsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Garran, Australia
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Hobart, Australia
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Kurralta Park, Australia
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Redcliffe, Australia
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Graz, Austria
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Linz, Austria
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Minsk, Belarus
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Edegem, Belgium
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Hasselt, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Bairro Nazare - Salvador, Brazil
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Campinas, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Lajeado - Rs, Brazil
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Ribeirao Preto - Sp, Brazil
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Rio de Janeiro Rj, Brazil
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São José do Rio Preto, Brazil
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São José dos Campos, Brazil
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São Paulo, Brazil
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Sorocaba - Sp, Brazil
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Plovdiv, Bulgaria
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Kelowna, British Columbia, Canada
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Lyon, France
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Braunschweig, Germany
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Durango Durango, Mexico
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Mexico City Distrito Federal, Mexico
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Bielsko-Biala, Poland
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San Juan, PR, Puerto Rico
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Bucharest, Romania
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Cluj-Napoca, Romania
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Nitra, Slovakia
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Prešov, Slovakia
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Žilina, Slovakia
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Cape Town, South Africa
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Durban, South Africa
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George, South Africa
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Port Elizabeth, South Africa
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A Coruña, Spain
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Madrid, Spain
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Majadahonda, Spain
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Pamplona, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Aarau, Switzerland
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Lausanne, Switzerland
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Winterthur, Switzerland
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Taipei, Taiwan
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Dnipropetrovsk, Ukraine
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Kyiv, Ukraine
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Zaporizhzhya, Ukraine
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Aberdeen, United Kingdom
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Northwood, United Kingdom
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Preston, United Kingdom
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Southampton, United Kingdom
Related Publications (3)
Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
PMID: 29272162DERIVEDSuri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.
PMID: 26031410DERIVEDSaad F, Fizazi K, Jinga V, Efstathiou E, Fong PC, Hart LL, Jones R, McDermott R, Wirth M, Suzuki K, MacLean DB, Wang L, Akaza H, Nelson J, Scher HI, Dreicer R, Webb IJ, de Wit R; ELM-PC 4 investigators. Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial. Lancet Oncol. 2015 Mar;16(3):338-48. doi: 10.1016/S1470-2045(15)70027-6. Epub 2015 Feb 18.
PMID: 25701170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 1, 2010
Study Start
October 1, 2010
Primary Completion
January 1, 2014
Study Completion
April 7, 2016
Last Updated
May 17, 2017
Results First Posted
May 17, 2017
Record last verified: 2017-04