Roll-over Study to Allow Continued Access to Ribociclib
Public ClinicalTrials.gov record NCT05161195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).
Study identification
- NCT ID
- NCT05161195
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Interventions
- Ribociclib Drug
- Letrozole Drug
- Anastrozole Drug
- Goserelin Drug
- Tamoxifen Drug
- Fulvestrant Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 6, 2022
- Primary completion
- Jun 27, 2030
- Completion
- Aug 13, 2030
- Last update posted
- Jun 22, 2026
2022 – 2030
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | — |
| Poudre Valley Hospital | Fort Collins | Colorado | 80528 | — |
| Mid Florida Hematology And Onc Ctr | Orange | Florida | 32763 | — |
| Summit Cancer Care | Savannah | Georgia | 31405 | — |
| John D Archbold Memorial Hospital | Thomasville | Georgia | 31792 | — |
| Duly Health and Care | Plainfield | Illinois | 60585 | — |
| Indian Univ Health Goshen Center forCancer | Goshen | Indiana | 46526 | — |
| Northern Light Mercy Hospital | Portland | Maine | 04102 | — |
| Englewood Health | Englewood | New Jersey | 07631 | — |
| The Valley Hospital-Luckow Pavillion | Paramus | New Jersey | 07652 | — |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | — |
| University Hospitals of Cleveland Seidman Cancer Center | Cleveland | Ohio | 44106 | — |
| Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma | 74136 | — |
| Millennium Research Clin Develop | Houston | Texas | 77090 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05161195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05161195 live on ClinicalTrials.gov.