Study Comparing Orteronel Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc. Identifier:
First received: August 31, 2010
Last updated: October 19, 2015
Last verified: October 2015
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

Condition Intervention Phase
Prostate Cancer
Drug: Orteronel + prednisone
Drug: Placebo + prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Radiographic progression-free survival (rPFS) [ Time Frame: Day 1 to radiographic disease progression or death ] [ Designated as safety issue: No ]
    Time from randomization to radiographic disease progression or death from any cause, whichever occurs first

  • Overall survival (OS) [ Time Frame: Time from date of patient randomization to the date of patient death due to any cause ] [ Designated as safety issue: No ]
    Overall survival

Secondary Outcome Measures:
  • 50% prostate specific antigen (PSA) response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    50% PSA response at 12 weeks

  • Changes in circulating tumor cell (CTC) counts [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Favorable changes in CTC levels at 24 weeks

  • Time to pain progression [ Time Frame: From randomization to the end of treatment ] [ Designated as safety issue: No ]
    Time to pain progression as measured by worst pain item in the Brief Pain Inventory-Short Form (BPI-SF) and changes in opioid analgesic use, if any

Enrollment: 1560
Study Start Date: October 2010
Study Completion Date: March 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orteronel + prednisone Drug: Orteronel + prednisone
Orteronel and 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 Comparator: Placebo + prednisone Drug: Placebo + prednisone
Placebo and prednisone 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

  • Voluntary written consent
  • 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:

Patients 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
  • 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
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Please refer to this study by its identifier: NCT01193244

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Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01193244     History of Changes
Other Study ID Numbers: C21004, 2010-018661-35, 0991413276
Study First Received: August 31, 2010
Last Updated: October 19, 2015
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Genital Diseases, Male
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015