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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193257
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief 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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Orteronel + prednisone Drug: Placebo + prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1099 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
Study Start Date : November 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Orteronel + prednisone Drug: Orteronel + prednisone
Orteronel and prednisone will be administered orally twice a day continuously throughout the study until disease progression is documented
Other Name: TAK-700

Placebo Comparator: Placebo + prednisone Drug: Placebo + prednisone
Placebo and prednisone will be administered orally twice a day continuously throughout the study until disease progression is documented

Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Time from patient randomization to death from any cause ]
    Patients will be followed for survival until 80% of patients have died or are lost to follow-up

Secondary Outcome Measures :
  1. 50% prostate specific antigen (PSA) response at 12 weeks [ Time Frame: 12 weeks ]
  2. Pain response at 12 weeks [ Time Frame: 12 weeks ]
  3. Radiographic progression-free survival (rPFS) [ Time Frame: Time from patient randomization to radiographic disease progression or death from any cause, whichever occurs first ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
  • Have progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received ≥ 360 mg/m2 of docetaxel within a 6-month period. Patients who were clearly intolerant to docetaxel or develop progressive disease before receiving ≥ 360 mg/m2 are also eligible if they have received at least 225 mg/m2 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, patients 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
  • Meet screening laboratory values as specified in protocol
  • Stable medical condition
  • Life expectancy of 6 months or more
  • Patients who have had up to 2 prior chemotherapy treatments are eligible to participate

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
  • 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 ro first dose of study drug (Patients 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
  • Patients whose prostate cancer is confined to just the prostrate bed or immediate adjacent tissue

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01193257

  Show 79 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01193257     History of Changes
Other Study ID Numbers: C21005
2010-018662-23 ( EudraCT Number )
CTR20131423 ( Registry Identifier: SFDA CTR )
0991413212 ( Registry Identifier: TCTIN )
C21005 ( Registry Identifier: NRES )
U1111-1181-8040 ( Registry Identifier: WHO )
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

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