Roll-over Study to Allow Continued Access to Ribociclib

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

Last Update: Jul 26, 2022

See if you pre-qualify

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.

Condition 
Metastatic Breast Cancer
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jul 07, 2022
Completion date 
Feb 16, 2028
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Ribociclib
Participants continue ribociclib as was administered in their parent study
Drug
Letrozole
Participants continue ribociclib in combination with letrozole as was administered in their parent study
Drug
Anastrozole
Participants continue ribociclib in combination with anastrozole as was administered in their parent study
Drug
Goserelin
Participants continue ribociclib in combination with goserelin as was administered in their parent study
Drug
Tamoxifen
Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
Drug
Fulvestrant
All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Eligibility Criteria

Key inclusion Criteria:

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)
Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
Currently has evidence of clinical benefit as determined by the Investigator

Key exclusion Criteria:

Permanent discontinuation of ribociclib in the parent study
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 Locations

United States
Mid Florida Hematology and Oncology Center
Recruiting
Orange City, 32763 - Florida
Contact: David Edwards (386-774-1223) - [email protected] - Santosh Nair
United States
Summit Cancer Care
Recruiting
Savannah, 31405 - Georgia
Contact: (912-651-5771) Alison Spellman
United States
John D Archbold Memorial Hospital
Recruiting
Thomasville, 31792 - Georgia
Contact: Kendall Fouler (229-228-2800) - [email protected] - Josh D. Simmons
United States
Millennium Research Clin Develop
Recruiting
Houston, 77090 - Texas
Contact: (832-561-1840) Isaac Levy
United States
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80 952
-
Poland
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119228
-
Singapore

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]