Phase I/II Open Label Dose Escalation Study of the 17α-Hydroxylase/ C17,20-Lyase Inhibitor, Abiraterone Acetate in Hormone Refractory Prostate Cancer
This is an open-label (identity of assigned study drug will be known) study to evaluate the
safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of
what a drug does to the body), and anti-tumor activities of abiraterone acetate (also known
as CB7630) in patients with HRPC. The study will be conducted in 2 phases (Phase 1 and Phase
2). In the first part of the study (Phase 1), the maximum tolerated dose (MTD) of
abiraterone acetate will be determined for use in the second part of the study (Phase 2)
where the number of patients who achieve at least a 50% decrease in prostate specific
antigen (PSA) during treatment with abiraterone acetate will be assessed (MTD from Phase 1).
Abiraterone acetate will be taken orally (by mouth) in fed and fasted patients once daily.
Doses of abiraterone acetate (starting at 250 mg up to a maximum of 2000 mg) will be taken
for 28-day treatment periods to determine the MTD. Patients will take MTD of abiraterone
acetate for up to twelve 28 day cycles (12 months; patients will be given the option of
staying on abiraterone acetate treatment if they are deriving benefit). In Phase 2,
prednisone or dexamethasone will be administered concurrently with abiraterone acetate.
Serial pharmacokinetic and pharmacodynamic samples will be collected and safety will be
monitored throughout the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1: maximum tolerated dose of CB7630
Up to Cycle 12, Day 28
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Fountain Valley, California 92708|
|Austin, Texas 78705|
|Massachussetts General Hospital Cancer Center||Boston, Massachusetts 02114|