A Pharmacokinetic and Pharmacodynamic Translational Investigation of Galeterone in Patients with Metastatic Castration Resistant Prostate Cancer - A Phase 2 Study of the Pharmacokinetics and Pharmacodynamics of galeterone for treatment of CRPC

Tokai Pharmaceuticals, Inc.0 sites24 target enrollmentOctober 15, 2013

Overview

No summary available.

Registry

who.int

Start Date

October 15, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\. Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
•2\. Male age \= 18 years
•3\. Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology)
•4\. Ongoing androgen blockade (therapy with gonadotropin\-releasing hormone (GnRH) analogues, or orchiectomy) demonstrated by serum testosterone concentration of less than 50 ng/dL
•5\. Demonstration of progression while on androgen blockade (based upon PCWG2 guidelines).
•Patients must have PSA levels that have risen on at least two successive occasions, at least 1 week apart, with the most recent PSA level \=2 ng/mL with or without the following:
•a. Nodal spread with no evidence of bone or visceral disease
•b. Bone disease with or without nodal disease and no evidence of visceral spread
•c. Visceral metastases with or without nodal or bone disease
•6\. Eastern Cooperative Oncology Group (ECOG) Performance Status \=2

•1\. Participation in another clinical trial involving experimental therapy \< 4 weeks prior to enrollment.
•2\. The following medications :
•a. Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK\-700, ARN\-509, ketoconazole\*, enzalutamide, or galeterone)
•\* In some cases of prior ketoconazole treatment, patients may be allowed to participate based upon discussion of the individual details between the PI and the Tokai Medical Representative.
•b. Prior treatment of CRPC with chemotherapy agents (including but not limited to taxanes, anthracyclines, mitoxantrone, platinators, etc.)
•c. Treatment with non\-steroidal oral antiandrogens (e.g. flutamide, bicalutamide or nilutamide), 5\-alpha reductase inhibitors, (e.g. dutasteride, finasteride) within 4 weeks of enrollment
•Note: Patients must show a continued rise in PSA (two consecutive measures at least 2 weeks apart) after the cessation of these therapies
•d. Use of herbal products that may decrease PSA levels (e.g., saw palmetto) within 4 weeks of enrollment or plans to initiate treatment with any of these herbal products during the trial
•e. Prior use of any chronic systemic glucocorticoids within the last 6 months (short course use at Tokai Medical Representative discretion) or plans to initiate treatment with chronic systemic glucocorticoids during the trial
•f. Prior external beam radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks)