Not provided
Not provided
Not provided
Not provided
Not provided
Change in corporate strategy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in combination.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elacestrant / Onapristone | Experimental | Elacestrant and Onapristone combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elacestrant | Drug | Elacestrant 200mg once daily oral dosing in cycles of 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety of elacestrant in combination with onapristone. | Monitor the treatment-related adverse events as assessed by CTCAE v4.0 | 7 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Onapristone | Drug | Onapristone 40mg twice daily oral dosing in cycles of 28 days. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626176 | elacestrant |
| C000626184 | RAD1901 |
| C053238 | onapristone |
Not provided
Not provided
Not provided