Trial record 1 of 1 for:    C21005
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Study Comparing Orteronel Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01193257
First received: August 31, 2010
Last updated: February 28, 2014
Last verified: February 2014

August 31, 2010
February 28, 2014
November 2010
May 2013   (final data collection date for primary outcome measure)
Overall survival (OS) [ Time Frame: Time from patient randomization to death from any cause ] [ Designated as safety issue: No ]
Patients will be followed for survival until 80% of patients have died or are lost to follow-up
To determine if orteronel plus prednisone improves overall survival (OS) [ Time Frame: Time from patient randomization to death from any cause ] [ Designated as safety issue: No ]
Patients will be followed for survival until 80% of patients have died or are lost to follow-up
Complete list of historical versions of study NCT01193257 on ClinicalTrials.gov Archive Site
  • 50% prostate specific antigen (PSA) response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pain response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Radiographic progression-free survival (rPFS) [ Time Frame: Time from patient randomization to radiographic disease progression or death from any cause, whichever occurs first ] [ Designated as safety issue: No ]
  • To determine if orteronel plus prednisone improves 50% prostate specific antigen (PSA) response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate whether orteronel plus prednisone improves pain response at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS) [ Time Frame: Time from patient randomization to radiographic disease progression or death from any cause, whichever occurs first ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Comparing Orteronel Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • Drug: Placebo + prednisone
    Placebo and prednisone will be administered orally twice a day continuously throughout the study until disease progression is documented
  • Experimental: Orteronel + prednisone
    Intervention: Drug: Orteronel + prednisone
  • Placebo Comparator: Placebo + prednisone
    Intervention: Drug: Placebo + prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1099
July 2013
May 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   Estonia,   Finland,   France,   Greece,   Hungary,   Italy,   Netherlands,   Poland,   Spain
 
NCT01193257
C21005, 2010-018662-23, CTR20131423
Yes
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP