Metastatic Castration Resistant Prostate Cancer MedDRA version: 14.1 Level: LLT Classification code 10066489 Term: Progression of prostate cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Galeterone
Product Code: TOK-001
Pharmaceutical Form: Tablet
INN or Proposed INN: GALETERONE
CAS Number: 851983-85-2
Other descriptive name: GALETERONE
Concentration unit: mg milligram(
Sponsors
Tokai Pharmaceuticals, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 7. Life expectancy of > 12 weeks 8. Able to swallow multiple tablets whole without crunching or breaking 9. Must have tumor deposits accessible for biopsy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial involving experimental therapy 50 ng/dL b. Measured or calculated creatinine clearance =50 ml/min (CKD-EPI calculation method) c. Bilirubin > 2.5x the ULN d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 5x the ULN e. Hemoglobin = 9.0 g/dL f. Absolute neutrophil count (ANC) = 1.5 x 109/L g. Platelets = 100 x 109/L h. Serum potassium (K+) 160 mmHg or diastolic blood pressure of > 100 mmHg measured on at least two occasions, two weeks apart) despite acceptable anti-hypertension therapy g. History of adrenal insufficiency or hyperaldosteronism h. Gastrointestinal disorders or gastric bypass surgery including lap bands that could interfere with the absorption of galeterone i. Serious active infections requiring systemic treatment or nonmalignant medical illnesses that are uncontrolled j. Any history of (in the past 5 years) second malignancy, other than treated non melanoma skin cancer and superficial transitional cell carcinoma of the bladder k. Active or uncontrolle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a. To evaluate efficacy of galeterone in terms of changes from baseline in PSA concentration b. To fully evaluate the pharmacokinetic profile of galeterone at steady state ;Secondary Objective: a. To further evaluate the safety profile of galeterone b. To determine efficacy of galeterone in terms of radiographic findings (DW-MRI) c. To assess changes in specific bone markers from baseline d. To correlate changes in circulating tumor cell (CTC) counts to outcome, and expression of (androgen receptor) AR in tumor biopsies and CTCs. e. To assess the changes in specific markers in steroidogenic pathways;Primary end point(s): Safety • Incidence and severity of AEs • Change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, and vital signs • Time matched triplicate ECGs • Treatment Compliance Efficacy Antitumor activity • Changes in histology on tumor biopsy samples • Changes in number of CTCs, AR status and any variants. Changes of CTC enumeration from baseline to Day 14 and end of study (Day 84, Trial Conclusion Visit). AR expression will be semi quantified at each of these time points PSA changes • Percentage of patients with 90%, 50% and 30% or greater decrease in PSA from baseline at end of treatment or PSA nadir (whichever comes first) • Maximal change in PSA response from baseline Imaging • Changes in magnetic resonance imaging (DW-MRI) • Changes in NaF PET uptake or standard PET (optional). Pharmacokinetics and Pharmacodynamics Translational Assessments • Changes from baseline of specific markers in steroidogenic pathway • Assessment of pharmacokinetics (PK) • Changes in bone makers (bone alkaline phosphatase, acid phosphatase, sCTX, uNTX, P1NP and TRAP-5b) • Changes in AR levels and histology in tumor biopsies from baseline to Day 28 and end of study (Day 84, Trial Conclusion Visit) • Assessment of galeterone concentration in serum. ;Timepoint(s) of evaluation of this end | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Spain, United Kingdom
Contacts
Public ContactClinical Trial Enquiries
Tokai Pharmaceuticals, Inc.
Outcome results
None listed