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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193244
• Other study ID #: C21004
• Secondary ID: 2010-018661-3509
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2010
• Last updated: July 13, 2016
• Start date: October 2010
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1560
• Est. completion date: April 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Orteronel
Orteronel 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
Placebo 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.
• Prednisone
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czech Republic,  Finland,  France,  Germany,  Greece,  Hong Kong,  Ireland,  Israel,  Italy,  Japan,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Peru,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic progression-free survival (rPFS)	Time from randomization to radiographic disease progression or death from any cause, whichever occurs first	Day 1 to radiographic disease progression or death	No
Primary	Overall survival (OS)	Overall survival	Time from date of patient randomization to the date of patient death due to any cause	No
Secondary	50% prostate specific antigen (PSA) response at 12 weeks	50% PSA response at 12 weeks	12 weeks	No
Secondary	Changes in circulating tumor cell (CTC) counts	Favorable changes in CTC levels at 24 weeks	24 weeks	No
Secondary	Time to pain progression	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	From randomization to the end of treatment	No