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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Radiographic progression-free survival (rPFS)

Outcome Description:

Time from randomization to radiographic disease progression or death from any cause, whichever occurs first

Outcome Time Frame:

Day 1 to radiographic disease progression or death

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C21004

NCT ID:

NCT01193244

Start Date:

May 2010

Completion Date:

June 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Anchorage, Alaska  
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Indianapolis, Indiana  
Charleston, South Carolina  
Las Vegas, Nevada  89109
Salt Lake City, Utah  84112