Phase 1-2 Study of Onapristone in Patients With Advanced Castration-resistant Prostate Cancer
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label, randomized, parallel group two-stage phase 1-2 study with an
escalation and an expansion component. This study will evaluate an extended-release (ER)
formulation of onapristone in patients with prostate cancer in which Progesterone Receptor
(PR) may be contributing to tumor progression. A companion diagnostic to select patients
whose prostate cancer expresses the activated form of the PR (APR) is under development and
will be implemented in this study; it may be used to further enrich the selection of the
population based upon ongoing review of the results. Patients will be treated until
occurrence of an intolerable safety issue, treatment failure, if patient elects to withdraw,
or for non-compliance with either protocol-specified evaluations or onapristone treatment. An
additional cohort of patients will be included at the recommended phase 2 dose to gain
additional understanding of the onapristone safety profile and potential anti-cancer
activity.