Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
Status: | Completed |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/20/2018 |
Start Date: | November 15, 2010 |
End Date: | February 29, 2016 |
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.
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
prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant
prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
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
We found this trial at
37
sites
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