Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.
5 other identifiers
interventional
1,099
13 countries
77
Brief Summary
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
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 Nov 2010
Typical duration for phase_3 prostate-cancer
77 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
November 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2016
CompletedResults Posted
Study results publicly available
December 19, 2018
CompletedDecember 19, 2018
November 1, 2018
2.5 years
August 31, 2010
February 27, 2017
November 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (approximately up to 4.5 years)
Secondary Outcomes (21)
Radiographic Progression-free Survival (rPFS)
Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)
Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12
Week 12
Percentage of Participants With Pain Response at Week 12
Week 12
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
Number of Participants With Abnormal Physical Examination Findings
Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
- +16 more secondary outcomes
Study Arms (2)
Orteronel + prednisone
EXPERIMENTALPlacebo + prednisone
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Voluntary written consent
- Male 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
- Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (\>=) 360 milligram per square meter (mg/m\^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving \>= 360 mg/m\^2 are also eligible if they have received at least 225 mg/m\^2 of docetaxel within a 6-month period and meet the other study entry criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse
- Screening laboratory values as specified in protocol
- Stable medical condition
- Life expectancy of 6 months or more
- Participants who have had up to 2 prior chemotherapy treatments are eligible to participate
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
- Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug
- Radioisotope therapy or external beam radiation therapy within 4 weeks of 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 (Participants who are in long-term follow-up following active treatment in other trials are eligible)
- 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
- Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel
- Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy
- Prostate cancer confined to just the prostrate bed or immediate adjacent tissue
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Unknown Facility
Anchorage, Alaska, 99508, United States
Unknown Facility
Fort Smith, Arkansas, 72903, United States
Unknown Facility
Fountain Valley, California, 92708, United States
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Los Angeles, California, 90025, United States
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Riverside, California, 92501, United States
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San Diego, California, 92120, United States
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Fort Myers, Florida, 33916, United States
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Port Saint Lucie, Florida, 34952, United States
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Indianapolis, Indiana, 46219, United States
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Jeffersonville, Indiana, 47130, United States
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New Orleans, Louisiana, 70112, United States
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Westminster, Maryland, 21157, United States
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Detroit, Michigan, 48201, United States
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Jefferson City, Missouri, 65109, United States
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Las Vegas, Nevada, 89169, United States
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Hackensack, New Jersey, 07601, United States
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Albany, New York, 12208, United States
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East Syracuse, New York, 13057, United States
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Rochester, New York, 14623, United States
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Raleigh, North Carolina, 27607, United States
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Cincinnati, Ohio, 45230, United States
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Tualatin, Oregon, 97062, United States
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Lancaster, Pennsylvania, 17604, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Greenville, South Carolina, 29605, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Amarillo, Texas, 79106, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75246, United States
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Odessa, Texas, 79761, United States
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Tyler, Texas, 75702, United States
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Webster, Texas, 77598, United States
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Salt Lake City, Utah, United States
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Newport News, Virginia, 23606, United States
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Kennewick, Washington, 99336, United States
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Redcliffe, Queensland, Australia
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Woodville South, South Australia, 5011, Australia
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Hobart, Tasmania, Australia
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Malvere, Victoria, Australia
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Wodonga, Victoria, Australia
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Brussels, Belgium
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Kortijk, Belgium
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Liège, Belgium
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Namur, Belgium
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, V1Y2H4, Canada
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Moncton, New Brunswick, Canada
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Brampton, Ontario, L6T4S5, Canada
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Newmarket, Ontario, Canada
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Greenfield Park, Quebec, J4V2H3, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, H9R4S3, Canada
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Hradec Dralove, Czechia
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Kromertz, Czechia
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Modřice, Czechia
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Prague, Czechia
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Zlín, Czechia
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Tallinn, Estonia
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Oulu, Finland
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Tampere, Finland
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La Roche-sur-Yon, France
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Le Mans, France
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Lyon, France
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Marseille, France
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Paris, France
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Villejuif, 94805, France
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Pátrai, Greece
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Miskolc, Hungary
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Osztaly, Hungary
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Novara, Italy
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Rome, Italy
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Eindhoven, Netherlands
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Bielsko-Biala, Poland
Unknown Facility
Goczałkowice Zdrój, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Seville, Spain
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: 26031410DERIVEDFizazi K, Jones R, Oudard S, Efstathiou E, Saad F, de Wit R, De Bono J, Cruz FM, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak DP, Lee SY, Webb IJ, Tejura B, Borgstein N, Dreicer R. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol. 2015 Mar 1;33(7):723-31. doi: 10.1200/JCO.2014.56.5119. Epub 2015 Jan 26.
PMID: 25624429DERIVED
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
November 15, 2010
Primary Completion
May 16, 2013
Study Completion
February 29, 2016
Last Updated
December 19, 2018
Results First Posted
December 19, 2018
Record last verified: 2018-11