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This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEE011 | Experimental | All patients in all combinations with LEE011 will be entered in one arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEE011 | Drug | Single agent LEE011 or in combination with other treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients enrolled and received LEE011 | Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study | up to 5 years (study duration) |
| Length of time receiving study treatment | Assessed by duration in days from start of study treatment until study treatment discontinuation | up to 5 years (study duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays. | The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs. | up to 5 years (study duration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| Dana Farber Cancer Institute |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| The Regents of the Uni of Michigan | Ann Arbor | Michigan | 48109-5930 | United States |
| Broome Oncology | Johnson City | New York | 13790 | United States |
| St Jude Childrens Research Hospital | Memphis | Tennessee | 38105 | United States |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Villejuif | 94800 | France |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Novartis Investigative Site | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Madrid | 28050 | Spain |
| Novartis Investigative Site | Tainan | 704302 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| ID | Term |
|---|---|
| C000589651 | ribociclib |
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