Roll-over Study to Allow Continued Access to Ribociclib
NCT ID: NCT05161195
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
134 participants
INTERVENTIONAL
2022-07-07
2030-08-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ribociclib
Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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Natal, Rio Grande do Norte, Brazil
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Ijuí, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sao Jose Rio Preto, , Brazil
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São Paulo, , Brazil
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Chongqing, Chongqing Municipality, China
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Shijiazhuang, Hebei, China
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Harbin, Heilongjiang, China
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Changsha, Hunan, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Changchun, Jilin, China
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Kunming, Yunnan, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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San José, , Costa Rica
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Heraklion Crete., , Greece
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Hong Kong, , Hong Kong
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Bhubaneshwar, Odisha, India
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Delhi, , India
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Meldola, FC, Italy
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Osaka, Osaka, Japan
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Bunkyo Ku, Tokyo, Japan
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Bunkyo Ku, Tokyo, Japan
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Koto Ku, Tokyo, Japan
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El Chouf, LBN, Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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San Pedro G G, , Mexico
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Trujillo, La Libertad, Peru
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San Borja, Lima region, Peru
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Gdansk, , Poland
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Lisbon, , Portugal
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Loures, , Portugal
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Porto, , Portugal
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Singapore, , Singapore
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Pretoria, , South Africa
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Sant Joan Despí, Barcelona, Spain
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Taipei, , Taiwan
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Taipei, , Taiwan
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Malatya, Battalgazi, Turkey (Türkiye)
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Diyarbakır, Sur, Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kecioren Ankara, , Turkey (Türkiye)
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Hanoi, , Vietnam
Countries
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Other Identifiers
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2024-514891-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLEE011A2412B
Identifier Type: -
Identifier Source: org_study_id
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