A Study Comparing Orteronel Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer, who have not had Chemotherapy

Overview

About this study

The purpose of this study is to evaluate orteronel (TAK-700) combined with prednisone, compared to a placebo and prednisone, for the treatment of men with progressive, metastatic, castration-resistant prostate cancer, who have not had chemotherapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Must meet all of the following
    • Voluntary written consent
    • Male
    • Age 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, 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
    • Meets screening laboratory values as specified in protocol
    • Stable medical condition

Exclusion Criteria

  • Must not meet any of the following
    • Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
    • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Manish Kohli, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Manish Kohli, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20315814

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