Trials / Terminated
TerminatedNCT02933801
ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.
ODM-201 Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Subsequent Treatment With a Taxane: A Multicenter Randomized Double-blind Placebo-controlled Phase II Trial.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Swiss Cancer Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.
Detailed description
The treatment of metastatic castration-resistant prostate cancer has evolved rapidly over the past few years. First line treatment with one of the novel antihormonal drugs abiraterone or enzalutamide followed by chemotherapy with docetaxel is now standard of care. If a patient has disease stabilization on chemotherapy he undergoes a watchful waiting period and further treatment is only started at the time of disease progression. This trial tests the immediate use of the novel androgen receptor antagonist ODM-201 as maintenance treatment after chemotherapy aiming at prolonging radiographic progression free survival as compared to watchful waiting. The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ODM-201 | ODM-201 will be given at a dose of 600 mg BID orally on a continuous basis. |
| OTHER | Placebo | Placebo will be given at a dose of 600 mg BID orally on a continuous basis. |
Timeline
- Start date
- 2017-03-31
- Primary completion
- 2021-06-28
- Completion
- 2023-11-15
- First posted
- 2016-10-14
- Last updated
- 2024-03-13
Locations
32 sites across 4 countries: France, Italy, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02933801. Inclusion in this directory is not an endorsement.