Prostate Cancer Clinical Trial

Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Each participant must meet all of the following inclusion criteria:

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

Exclusion Criteria:

Participants 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
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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1099

Study ID:

NCT01193257

Recruitment Status:

Completed

Sponsor:

Millennium Pharmaceuticals, Inc.

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There are 42 Locations for this study

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Anchorage Alaska, 99508, United States

Fort Smith Arkansas, 72903, United States

Fountain Valley California, 92708, United States

Los Angeles California, 90025, United States

Riverside California, 92501, United States

San Diego California, 92120, United States

Fort Myers Florida, 33916, United States

Port Saint Lucie Florida, 34952, United States

Indianapolis Indiana, 46219, United States

Jeffersonville Indiana, 47130, United States

New Orleans Louisiana, 70112, United States

Westminster Maryland, 21157, United States

Detroit Michigan, 48201, United States

Jefferson City Missouri, 65109, United States

Las Vegas Nevada, 89169, United States

Hackensack New Jersey, 07601, United States

Albany New York, 12208, United States

East Syracuse New York, 13057, United States

Rochester New York, 14623, United States

Raleigh North Carolina, 27607, United States

Cincinnati Ohio, 45230, United States

Tualatin Oregon, 97062, United States

Lancaster Pennsylvania, 17604, United States

Pittsburgh Pennsylvania, 15212, United States

Greenville South Carolina, 29605, United States

Chattanooga Tennessee, 37404, United States

Nashville Tennessee, 37203, United States

Amarillo Texas, 79106, United States

Bedford Texas, 76022, United States

Dallas Texas, 75231, United States

Dallas Texas, 75246, United States

Odessa Texas, 79761, United States

Tyler Texas, 75702, United States

Webster Texas, 77598, United States

Salt Lake City Utah, , United States

Newport News Virginia, 23606, United States

Kennewick Washington, 99336, United States

Redcliffe Queensland, , Australia

Woodville South South Australia, 5011, Australia

Hobart Tasmania, , Australia

Malvere Victoria, , Australia

Wodonga Victoria, , Australia

Brussels , , Belgium

Kortijk , , Belgium

Liege , , Belgium

Namur , , Belgium

Edmonton Alberta, , Canada

Kelowna British Columbia, V1Y2H, Canada

Moncton New Brunswick, , Canada

Brampton Ontario, L6T4S, Canada

Newmarket Ontario, , Canada

Greenfield Park Quebec, J4V2H, Canada

Montreal Quebec, , Canada

Pointe-Claire Quebec, H9R4S, Canada

Hradec Dralove , , Czechia

Kromertz , , Czechia

Modrice , , Czechia

Praha , , Czechia

Zlin , , Czechia

Tallinn , , Estonia

Oulu , , Finland

Tampere , , Finland

La Roche-sur-Yon , , France

Le Mans , , France

Lyon Cedex , , France

Lyon , , France

Marseille , , France

Paris , , France

Villejuif cedex , 94805, France

Patras , , Greece

Miskolc , , Hungary

Osztaly , , Hungary

Novara , , Italy

Rome , , Italy

Eindhoven , , Netherlands

Bielsko-Biala , , Poland

Goczalkowice-Zdroj , , Poland

Wroclaw , , Poland

Sevilla , , Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1099

Study ID:

NCT01193257

Recruitment Status:

Completed

Sponsor:


Millennium Pharmaceuticals, Inc.

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