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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


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

Thank you

Trial Information

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


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

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:

Overall survival (OS)

Outcome Description:

Patients will be followed for survival until 80% of patients have died or are lost to follow-up

Outcome Time Frame:

Time from patient randomization to death from any cause

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:

C21005

NCT ID:

NCT01193257

Start Date:

November 2010

Completion Date:

July 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Anchorage, Alaska  
Baltimore, Maryland  21287
Charlotte, North Carolina  
Eugene, Oregon  
Indianapolis, Indiana  
Charleston, South Carolina  
Las Vegas, Nevada  89109
Salt Lake City, Utah  84112