Clinical trial NCT05161195: Roll-over Study to Allow Continued Access to Ribociclib
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Keywords: Roll-over Protocol
Ribociclib
HR-positive
HER2-negative
Breast Cancer
Ribociclib in combination with other drugs
LEE011
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

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

Primary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (AES)
timeFrame: From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years
Secondary outcomes:
measure: Clinical benefit rate
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Orange
country: United States
facility: Mid Florida Hematology And Onc Ctr
state: Florida
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Thomasville
country: United States
facility: John D Archbold Memorial Hospital
state: Georgia
city: Plainfield
country: United States
facility: Duly Health and Care
state: Illinois
city: Goshen
country: United States
facility: Indian Univ Health Goshen Center forCancer
state: Indiana
city: Portland
country: United States
facility: Northern Light Mercy Hospital
state: Maine
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital-Luckow Pavillion
state: New Jersey
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Seidman Cancer Center
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Houston
country: United States
facility: Millennium Research Clin Develop
state: Texas
city: San Juan
country: Argentina
facility: Novartis Investigative Site
city: Natal
country: Brazil
facility: Novartis Investigative Site
state: RN
city: Ijui
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Florianopolis
country: Brazil
facility: Novartis Investigative Site
state: SC
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Chang Chun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Kunming
country: China
facility: Novartis Investigative Site
state: Yunnan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Qingdao
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: San Jose
country: Costa Rica
facility: Novartis Investigative Site
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Pokfulam
country: Hong Kong
facility: Novartis Investigative Site
city: Bhubaneshwar
country: India
facility: Novartis Investigative Site
state: Orissa
city: Delhi
country: India
facility: Novartis Investigative Site
city: Meldola
country: Italy
facility: Novartis Investigative Site
state: FC
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: El Chouf
country: Lebanon
facility: Novartis Investigative Site
state: LBN
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: San Pedro Garza Garcia
country: Mexico
facility: Novartis Investigative Site
city: Trujillo
country: Peru
facility: Novartis Investigative Site
state: La Libertad
city: San Borja
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Loures
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Sant Joan Despi
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Diyarbakir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kecioren Ankara
country: Turkey
facility: Novartis Investigative Site
city: Malatya
country: Turkey
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: