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NCT05161195 Clinical Trial

Roll-over Study to Allow Continued Access to Ribociclib

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05161195
Other study ID # CLEE011A2412B
Secondary ID 2021-005184-42
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 7, 2022
Est. completion date March 26, 2030

Study information
Verified date June 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 137
Est. completion date March 26, 2030
Est. primary completion date February 26, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Argentina Novartis Investigative Site San Juan
Brazil Novartis Investigative Site Florianopolis SC
Brazil Novartis Investigative Site Ijuí RS
Brazil Novartis Investigative Site Natal RN
Brazil Novartis Investigative Site Sao Jose do Rio Preto
Brazil Novartis Investigative Site Sao Paulo
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site São Paulo SP
Costa Rica Novartis Investigative Site San Jose
Greece Novartis Investigative Site Heraklion Crete
Hong Kong Novartis Investigative Site Hong Kong
Hong Kong Novartis Investigative Site Shatin New Territories
Italy Novartis Investigative Site Meldola FC
Japan Novartis Investigative Site Bunkyo ku Tokyo
Japan Novartis Investigative Site Bunkyo ku Tokyo
Japan Novartis Investigative Site Koto ku Tokyo
Japan Novartis Investigative Site Osaka-city Osaka
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Lebanon Novartis Investigative Site Ashrafieh
Lebanon Novartis Investigative Site Beirut
Lebanon Novartis Investigative Site El Chouf LBN
Mexico Novartis Investigative Site San Pedro Garza Garcia
Poland Novartis Investigative Site Gdansk
Portugal Novartis Investigative Site Lisboa
Singapore Novartis Investigative Site Singapore
South Africa Novartis Investigative Site Cape Town
South Africa Novartis Investigative Site Johannesburg
South Africa Novartis Investigative Site Pretoria
Spain Novartis Investigative Site Sant Joan Despi Barcelona
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
Turkey Novartis Investigative Site Diyarbakir
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Kecioren Ankara
Turkey Novartis Investigative Site Malatya
United States Beverly Hills Cancer Center Beverly Hills California
United States Eastchester Center for Cancer Care Bronx New York
United States Ironwood Cancer and Research Centers Chandler Arizona
United States University Hospitals of Cleveland Seidman Cancer Center Cleveland Ohio
United States Englewood Health Englewood New Jersey
United States Highlands Oncology Group Fayetteville Arkansas
United States Poudre Valley Hospital Fort Collins Colorado
United States Indian Univ Health Goshen Center forCancer Goshen Indiana
United States Millennium Research Clin Develop Houston Texas
United States Mid Florida Hematology And Onc Ctr Orange Florida
United States The Valley Hospital Luckow Pavillion Paramus New Jersey
United States Duly Health and Care Plainfield Illinois
United States Northern Light Mercy Hospital Portland Maine
United States Summit Cancer Care Savannah Georgia
United States John D Archbold Memorial Hospital Thomasville Georgia
United States Oklahoma Cancer Specialists and Research Institute Tulsa Oklahoma
Vietnam Novartis Investigative Site Hanoi

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Brazil,  Costa Rica,  Greece,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Mexico,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Taiwan,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants with treatment-emergent adverse events (AES) 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 From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years
Secondary Clinical benefit rate Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits Up to 5 years
See also
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