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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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be withdrawn by the patient at any time without prejudice to future medical care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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Percentage of patients with serum testosterone levels reduced to ≤ 2 ng/dL

Outcome 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)

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:

C21013

NCT ID:

NCT01666314

Start Date:

September 2012

Completion Date:

March 2014

Related Keywords:

  • Prostate Cancer
  • castrate resistant prostate cancer,
  • CRPC,
  • orteronel,
  • TAK-700
  • Prostatic Neoplasms

Name

Location

Urology Cancer Center, PCOmaha, Nebraska  68130