Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies Clinical Trial
Official title:
An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | September 1, 2026 |
| Est. primary completion date | August 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 80 Years |
| Eligibility | Inclusion Criteria: 1. Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment. 2. Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator. Exclusion Criteria: 1. Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason. 2. Patients who do not meet parent protocol criteria to continue study treatment. |
| Country | Name | City | State |
|---|---|---|---|
| France | Novartis Investigative Site | Lyon | |
| France | Novartis Investigative Site | Villejuif | |
| Singapore | Novartis Investigative Site | Singapore | |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Taiwan | Novartis Investigative Site | Tainan | |
| Taiwan | Novartis Investigative Site | Taipei | |
| United States | The Regents of the University of Michigan | Ann Arbor | Michigan |
| United States | University Of Alabama At Birmingham | Birmingham | Alabama |
| United States | Dana Farber Cancer Institute Main Site | Boston | Massachusetts |
| United States | Broome Oncology SC-2 | Johnson City | New York |
| United States | St Jude Childrens Research Hospital | Memphis | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, France, Singapore, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Secondary | 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) |