DRUG
Ribociclib
Participants continue ribociclib as was administered in their parent study
Status
Active, not recruiting
Phase
Phase 4
Enrollment
134
Locations
73
Results
Not posted
Publications
0
Study summary
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).
This is an open-label, multi-center, roll-over study to evaluate the long-term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment. This roll-over study will not include a screening phase, participants will directly transfer at the completion of the parent study. Eligible participants will start receiving ribociclib in combination with other drugs (as per parent protocol) only after they have signed the Informed Consent and have met the selection criteria for this roll-over study. Participants should return to the study center for resupply of the study medication and for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more frequently at any given time required as per local practice.
Interventions
DRUG
Participants continue ribociclib as was administered in their parent study
DRUG
Participants continue ribociclib in combination with letrozole as was administered in their parent study
DRUG
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
DRUG
Participants continue ribociclib in combination with goserelin as was administered in their parent study
DRUG
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
DRUG
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
Timeline
First posted
Dec 17, 2021
Study start
Jul 7, 2022
Primary completion
Jun 28, 2030
Study completion
Aug 14, 2030
Results posted
Not reported
Registry updated
Jun 23, 2026
Outcomes
Percentage of participants with treatment-emergent adverse events (AES)
Time frame · From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years
The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment
Clinical benefit rate
Time frame · Up to 8 years
Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits
Eligibility
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs and the parent study has fulfilled its primary objective(s). * Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. * Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study. * Participant must have evidence of clinical benefit as determined by the Investigator. Key Exclusion Criteria: * Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol. * Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume). * Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria). * Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include: 1. Total abstinence 2. Female sterilization 3. Male partner sterilization 4. Placement of an intrauterine device (IUD) * Male contraception during ribociclib use by male participants is not required unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations. Other protocol-defined inclusion/exclusion criteria may apply.
Study locations
Argentina · Brazil · China · Costa Rica · Greece · Hong Kong · India · Italy · Japan · Lebanon · Mexico · Peru · Poland · Portugal · Singapore · South Africa · South Korea · Spain · Taiwan · Turkey (Türkiye) · United States · Vietnam. Showing up to 24 locations stored in the fast local snapshot.
Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Mid Florida Hematology And Onc Ctr
Orange, Florida, United States
Summit Cancer Care
Savannah, Georgia, United States
John D Archbold Memorial Hospital
Thomasville, Georgia, United States
Duly Health and Care
Plainfield, Illinois, United States
Indian Univ Health Goshen Center forCancer
Goshen, Indiana, United States
Northern Light Mercy Hospital
Portland, Maine, United States
Englewood Health
Englewood, New Jersey, United States
The Valley Hospital-Luckow Pavillion
Paramus, New Jersey, United States
Eastchester Center for Cancer Care
The Bronx, New York, United States
University Hospitals of Cleveland Seidman Cancer Center
Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
Millennium Research Clin Develop
Houston, Texas, United States
Novartis Investigative Site
San Juan, Argentina
Novartis Investigative Site
Natal, Rio Grande do Norte, Brazil
Novartis Investigative Site
Ijuí, Rio Grande do Sul, Brazil
Novartis Investigative Site
Florianópolis, Santa Catarina, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Sao Jose Rio Preto, Brazil
Novartis Investigative Site
São Paulo, Brazil
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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