Last Update: Jun 13, 2024
A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
ClinicalTrials.gov Identifier:
NCT05161195
Novartis Reference Number:CLEE011A2412B
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. The purpose of this study is to evaluate long-term safety and provide continued treatment
to participants who are currently receiving ribociclib in combination with other drugs in
a parent study, that has fulfilled requirements for its primary objective(s), and in the
opinion of the Investigator, would benefit from continuing treatment at time of
discontinuation from the parent study

Metastatic Breast Cancer
Phase4
Recruiting
137
Jul 07, 2022
Mar 26, 2030
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Anastrozole

Participants continue ribociclib in combination with anastrozole as was administered in their parent study
Drug

Fulvestrant

All participants continue ribociclib in combination with fulvestrant as was administered in their parent study
Drug

Goserelin

Participants continue ribociclib in combination with goserelin as was administered in their parent study
Drug

Letrozole

Participants continue ribociclib in combination with letrozole as was administered in their parent study
Drug

Ribociclib

Participants continue ribociclib as was administered in their parent study
Drug

Tamoxifen

Participants continue ribociclib in combination with tamoxifen as was administered in their parent study

Eligibility Criteria

Key inclusion Criteria:

1. 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)

2. Must have been receiving treatment with ribociclib for at least 6 cycles in the
parent study

3. Currently has evidence of clinical benefit as determined by the Investigator

Key exclusion Criteria:

1. Permanent discontinuation of ribociclib in the parent study

2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted
in the parent study 3. Local access to commercially available ribociclib and
reimbursed

Other protocol-defined inclusion/exclusion criteria may apply at the end

Study Location

Novartis Investigative Site

Recruiting

San Juan,J5402dil,Argentina

Novartis Investigative Site

Recruiting

Sao Paulo,SP,01317 000,Brazil

Novartis Investigative Site

Recruiting

Natal,RN,59075 740,Brazil

Novartis Investigative Site

Recruiting

Ijuí,RS,98700-000,Brazil

Novartis Investigative Site

Recruiting

São Paulo,SP,03102,Brazil

Novartis Investigative Site

Recruiting

Florianopolis,SC,88034-000,Brazil

Novartis Investigative Site

Recruiting

Sao Jose do Rio Preto,15090 000,Brazil

Novartis Investigative Site

Recruiting

Sao Paulo,01255-000,Brazil

Novartis Investigative Site

Recruiting

San Jose,95008,Costa Rica

Novartis Investigative Site

Recruiting

Shatin New Territories,Hong Kong

Novartis Investigative Site

Recruiting

Meldola,FC,47014,Italy

Novartis Investigative Site

Recruiting

Gdansk,80 952,Poland

Novartis Investigative Site

Recruiting

Cape Town,7500,South Africa

Novartis Investigative Site

Recruiting

Pretoria,0002,South Africa

Novartis Investigative Site

Recruiting

Johannesburg,2196,South Africa

Novartis Investigative Site

Recruiting

Taipei,10041,Taiwan

Novartis Investigative Site

Recruiting

Taipei,103616,Taiwan

Novartis Investigative Site

Recruiting

Izmir,35040,Turkey

Novartis Investigative Site

Recruiting

Diyarbakir,21000,Turkey

Novartis Investigative Site

Recruiting

Kecioren Ankara,06010,Turkey

Novartis Investigative Site

Recruiting

Malatya,44280,Turkey

Millennium Research Clin Develop

Recruiting

Houston,Texas,77090,United States

Summit Cancer Care

Recruiting

Savannah,Georgia,31405,United States

Englewood Health

Recruiting

Englewood,New Jersey,07631,United States

Northern Light Mercy Hospital

Recruiting

Portland,Maine,04102,United States

The Valley Hospital Luckow Pavillion

Recruiting

Paramus,New Jersey,07652,United States

Highlands Oncology Group

Recruiting

Fayetteville,Arkansas,72703,United States

Indian Univ Health Goshen Center forCancer

Recruiting

Goshen,Indiana,46526,United States

University Hospitals of Cleveland Seidman Cancer Center

Recruiting

Cleveland,Ohio,44106,United States

Ironwood Cancer and Research Centers

Recruiting

Chandler,Arizona,85224,United States

John D Archbold Memorial Hospital

Recruiting

Thomasville,Georgia,31792,United States

Beverly Hills Cancer Center

Recruiting

Beverly Hills,California,90211,United States

Mid Florida Hematology And Onc Ctr

Recruiting

Orange,Florida,32763,United States

Oklahoma Cancer Specialists and Research Institute

Recruiting

Tulsa,Oklahoma,74136,United States

Duly Health and Care

Recruiting

Plainfield,Illinois,60585,United States

Novartis Investigative Site

Recruiting

Hanoi,100000,Vietnam

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111

Novartis Pharmaceuticals

1-888-669-6682