Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT01193244
Last Updated: 2017-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1560 participants
INTERVENTIONAL
2010-10-01
2016-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Orteronel + prednisone
Orteronel
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.
Prednisone
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 + prednisone
Placebo
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
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.
Interventions
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Orteronel
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
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
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
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Inclusion Criteria
* 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
* 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
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
Tucson, Arizona, United States
Duarte, California, United States
Highland, California, United States
Orange, California, United States
Sacramento, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Deerfield Beach, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Port Saint Lucie, Florida, United States
Jeffersonville, Indiana, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Lansing, Michigan, United States
Duluth, Minnesota, United States
Corinth, Mississippi, United States
Columbia, Missouri, United States
Jefferson City, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
East Syracuse, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Kettering, Ohio, United States
Tualatin, Oregon, United States
Hershey, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Piitsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
Denton, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Garran, , Australia
Hobart, , Australia
Kurralta Park, , Australia
Nedlands, , Australia
Perth, , Australia
Redcliffe, , Australia
Wodonga, , Australia
Graz, , Austria
Linz, , Austria
Vienna, , Austria
Minsk, , Belarus
Edegem, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Namur, , Belgium
Bairro Nazare - Salvador, , Brazil
Barretos/sp, , Brazil
Belo Horizonte, , Brazil
Campinas, , Brazil
Caxias do Sul, , Brazil
Curitiba, , Brazil
Fortaleza/ce, , Brazil
Ijuí, , Brazil
Joinville, , Brazil
Lajeado - Rs, , Brazil
Piracicaba - Sp, , Brazil
Porto Alegre- Rs, , Brazil
Porto Alegre/rs, , Brazil
Ribeirao Preto - Sp, , Brazil
Rio de Janeiro, , Brazil
Rio de Janeiro Rj, , Brazil
Santo André, , Brazil
São José do Rio Preto, , Brazil
São José dos Campos, , Brazil
São Paulo, , Brazil
Sorocaba - Sp, , Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Kelowna, British Columbia, Canada
Burlington, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Owen Sound, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Las Condes, , Chile
Santiago, , Chile
Temuco, , Chile
Valparaíso, , Chile
Cali, , Colombia
Hradec Králové, , Czechia
Prague, , Czechia
Joensuu, , Finland
Oulu, , Finland
Seinäjoki, , Finland
Tampere, , Finland
Angers, , France
Bordeaux, , France
Caen, , France
Créteil, , France
La Roche-sur-Yon, , France
Lyon, , France
Marseille, , France
Nancy, , France
Nantes, , France
Paris, , France
Poitiers, , France
Saint-Etienne, , France
Villejuif, , France
Braunschweig, , Germany
Dresden, , Germany
Hamburg, , Germany
Hanover, , Germany
Kassel, , Germany
Kempen, , Germany
Nürtingen, , Germany
Tübingen, , Germany
Wuppertal, , Germany
Athens, , Greece
Heraklion Crete, , Greece
Larissa, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Kowloon, , Hong Kong
Shatin, , Hong Kong
Dublin, , Ireland
Galway, , Ireland
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Aviano, , Italy
Novara, , Italy
Roma, , Italy
Torino, , Italy
Chiba, , Japan
Fukuoka, , Japan
Hamamatsu, , Japan
Hokkaido, , Japan
Kanazawa, , Japan
Kita-gun, , Japan
Maebashi, , Japan
Mito, , Japan
Osaka, , Japan
Sakura, , Japan
Sayama, , Japan
Sendai, , Japan
Shimizucho Sunto-gun, , Japan
Suntou-gun, , Japan
Tokyo, , Japan
Yamagata, , Japan
Yokohama, , Japan
Yufu, , Japan
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Durango Durango, , Mexico
Mexico City Distrito Federal, , Mexico
Zapopan Jalisco, , Mexico
Amsterdam, , Netherlands
Arnhem, , Netherlands
Breda, , Netherlands
Eindhoven, , Netherlands
Heerlen, , Netherlands
Nieuwegein, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Takapuna, , New Zealand
Tauranga, , New Zealand
Lima, , Peru
Bielsko-Biala, , Poland
Wroclaw, , Poland
Liepaja, , Portugal
Lisbon, , Portugal
Porto, , Portugal
San Juan, PR, Puerto Rico
Bucharest, , Romania
Cluj-Napoca, , Romania
Moscow, , Russia
Saint Petersburg, , Russia
Singapore, , Singapore
Nitra, , Slovakia
Prešov, , Slovakia
Trenčín, , Slovakia
Žilina, , Slovakia
Cape Town, , South Africa
Durban, , South Africa
George, , South Africa
Port Elizabeth, , South Africa
A Coruña, , Spain
Barcelona, , Spain
Madrid, , Spain
Majadahonda, , Spain
Pamplona, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Aarau, , Switzerland
Lausanne, , Switzerland
Winterthur, , Switzerland
Zurich, , Switzerland
Taichung, , Taiwan
Taipei, , Taiwan
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kyiv, , Ukraine
Zaporizhzhya, , Ukraine
Aberdeen, , United Kingdom
Belfast, , United Kingdom
Bristol, , United Kingdom
Cottingham, , United Kingdom
Coventry, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Northwood, , United Kingdom
Preston, , United Kingdom
Southampton, , United Kingdom
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.
Saad 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.
Other Identifiers
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2010-018661-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0991413276
Identifier Type: OTHER
Identifier Source: secondary_id
10/H0406/75
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1181-0387
Identifier Type: REGISTRY
Identifier Source: secondary_id
C21004
Identifier Type: -
Identifier Source: org_study_id
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