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: March 4, 2016
Last verified: March 2016
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01193244

  Show 245 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

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: March 4, 2016
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 22, 2016