Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer - Full Text View

Purpose

This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

Condition	Intervention	Phase
Prostate Cancer	Drug: orteronel 200mg/300mg Drug: orteronel 200mg/400mg Drug: Placebo	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Steroids

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:

Percentage of patients with serum testosterone levels reduced to ≤ 2 ng/dL [ Time Frame: Serum testosterone level in patients at screening; Cycle 1-Day 1, 8, 15, and 22; Cycle 2, 3, 4, and 5 - Day 1. Each cycle is a 28-day cycle (upto 140 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with serum testosterone levels reduced to ≤ 2 ng/dL [ Time Frame: Serum testosterone level in patients at screening; Cycle 1-Day 1, 8, 15, and 22; Cycle 2, 3, 4, and 5 - Day 1. Each cycle is a 28-day cycle (upto 140 days) ] [ Designated as safety issue: No ]
Serum testosterone level [ Time Frame: Change in the serum testosterone level at screening; Cycle 1-Day 1, 8, 15, and 22; Cycle 2, 3, 4, and 5 - Day 1. Each cycle is a 28-day cycle (upto 140 days) ] [ Designated as safety issue: No ]
PSA reduction ≥ 50% [ Time Frame: At screening, Cycle 1, 2, 3, 4 and 5- Day 1. Each cycle is a 28-day cycle. ] [ Designated as safety issue: No ]
Pharmacodynamic effects of orteronel measured by endocrine markers plotted over time [ Time Frame: At screening; Cycle 1-Day 1, 8, 15, and 22; Cycle 2, 3, 4, and 5 - Day 1. Each cycle is a 28-day cycle ] [ Designated as safety issue: No ]
PK parameters for orteronel, including, but not limited to, Cmax, Area under Curve (AUC),Tmax, and the cumulative amount of unchanged drug excreted into the urine (Ae) in all treatment groups [ Time Frame: Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose ] [ Designated as safety issue: No ]
Number of adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values, vital sign measurements, physical examination findings, and electrocardiograms (ECGs) in all treatment groups [ Time Frame: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 2.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	144
Study Start Date:	September 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: orteronel 200mg/300mg orteronel + Prednisone	Drug: orteronel 200mg/300mg Patients will be randomized to receive orteronel 200 mg BID or orteronel 300 mg BID Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg BID continuously throughout the study.
Experimental: orteronel 200mg/400mg orteronel + Prednisone	Drug: orteronel 200mg/400mg Patients will be randomized to receive orteronel 200 mg BID or orteronel 400 mg BID. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg BID continuously throughout the study.
Experimental: Placebo Placebo + Prednisone	Drug: Placebo Patients will be randomized to receive placebo (Cycle 1 only). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg BID continuously throughout the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male patients 18 years or older
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
Prior surgical castration or concurrent use of an agent for medical castration (e.g. GnRH analogue)
PSA ≥ 2 ng/mL at screening
Progressive disease based on PSA and/or radiographic criteria

Exclusion Criteria:

Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5- alpha reductase inhibitors (eg, finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [eg, joint injection] are allowed).
Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666314

Contacts

Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center

1-866-835-2233

medical@mlnm.com

Locations

United States, Nebraska
Urology Cancer Center, PC	Recruiting
Omaha, Nebraska, United States, 68130

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Medical Monitor

Millennium Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01666314 History of Changes
Other Study ID Numbers:	C21013, 2012-001539-30
Study First Received:	August 6, 2012
Last Updated:	January 23, 2013
Health Authority:	United States: Food and Drug Administration European Union: European Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:

castrate resistant prostate cancer,
CRPC,
orteronel,
TAK-700

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013