Trials / Unknown
UnknownNCT02049190
Phase 1-2 Study of Onapristone in Patients With Advanced Castration-resistant Prostate Cancer
A Phase 1-2 Study of Onapristone in Patients With Advanced Castration-resistant Prostate Cancer
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Arno Therapeutics · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Prostate Cancer
- Metastatic Prostate Cancer
- Androgen-independent Prostate Cancer
- Recurrent Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | onapristone | |
| DRUG | abiraterone |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2017-07-01
- Completion
- 2017-12-01
- First posted
- 2014-01-30
- Last updated
- 2015-06-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02049190. Inclusion in this directory is not an endorsement.