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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01666314
First received: August 6, 2012
Last updated: January 31, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 137
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Nebraska
Urology Cancer Center, PC
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 31, 2014
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 October 01, 2014