Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
NCT ID: NCT01193257
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1099 participants
INTERVENTIONAL
2010-11-15
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Orteronel + prednisone
Orteronel
Orteronel tablets
Prednisone
Prednisone tablets
Placebo + prednisone
Prednisone
Prednisone tablets
Orteronel Placebo
Orteronel placebo-matching tablets
Interventions
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Orteronel
Orteronel tablets
Prednisone
Prednisone tablets
Orteronel Placebo
Orteronel placebo-matching tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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Anchorage, Alaska, United States
Fort Smith, Arkansas, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Riverside, California, United States
San Diego, California, United States
Fort Myers, Florida, United States
Port Saint Lucie, Florida, United States
Indianapolis, Indiana, United States
Jeffersonville, Indiana, United States
New Orleans, Louisiana, United States
Westminster, Maryland, United States
Detroit, Michigan, United States
Jefferson City, Missouri, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
Albany, New York, United States
East Syracuse, New York, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Tualatin, Oregon, United States
Lancaster, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Odessa, Texas, United States
Tyler, Texas, United States
Webster, Texas, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
Kennewick, Washington, United States
Redcliffe, Queensland, Australia
Woodville South, South Australia, Australia
Hobart, Tasmania, Australia
Malvere, Victoria, Australia
Wodonga, Victoria, Australia
Brussels, , Belgium
Kortijk, , Belgium
Liège, , Belgium
Namur, , Belgium
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Moncton, New Brunswick, Canada
Brampton, Ontario, Canada
Newmarket, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Hradec Dralove, , Czechia
Kromertz, , Czechia
Modřice, , Czechia
Prague, , Czechia
Zlín, , Czechia
Tallinn, , Estonia
Oulu, , Finland
Tampere, , Finland
La Roche-sur-Yon, , France
Le Mans, , France
Lyon, , France
Marseille, , France
Paris, , France
Villejuif, , France
Pátrai, , Greece
Miskolc, , Hungary
Osztaly, , Hungary
Novara, , Italy
Rome, , Italy
Eindhoven, , Netherlands
Bielsko-Biala, , Poland
Goczałkowice Zdrój, , Poland
Wroclaw, , Poland
Seville, , Spain
Countries
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References
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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.
Suri 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.
Fizazi 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.
Other Identifiers
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2010-018662-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20131423
Identifier Type: REGISTRY
Identifier Source: secondary_id
0991413212
Identifier Type: REGISTRY
Identifier Source: secondary_id
C21005
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1181-8040
Identifier Type: REGISTRY
Identifier Source: secondary_id
C21005
Identifier Type: -
Identifier Source: org_study_id