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Clinical Trials in India / NCT05161195
Active, not recruiting Phase 4

Roll-over Study to Allow Continued Access to Ribociclib

NCT05161195 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Started
2022-07-07
Last updated
2026-06-23

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

RibociclibLetrozoleAnastrozoleGoserelinTamoxifenFulvestrant

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

Study summary

The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * 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. Key Exclusion Criteria: * Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol. * 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. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
Ironwood Cancer and Research Centers Chandler Arizona
Highlands Oncology Group Fayetteville Arkansas
Beverly Hills Cancer Center Beverly Hills California
Poudre Valley Hospital Fort Collins Colorado
Mid Florida Hematology And Onc Ctr Orange Florida
Summit Cancer Care Savannah Georgia
John D Archbold Memorial Hospital Thomasville Georgia
Duly Health and Care Plainfield Illinois
Indian Univ Health Goshen Center forCancer Goshen Indiana
Northern Light Mercy Hospital Portland Maine
Englewood Health Englewood New Jersey
The Valley Hospital-Luckow Pavillion Paramus New Jersey
Eastchester Center for Cancer Care The Bronx New York
University Hospitals of Cleveland Seidman Cancer Center Cleveland Ohio
Oklahoma Cancer Specialists and Research Institute Tulsa Oklahoma
Millennium Research Clin Develop Houston Texas
Novartis Investigative Site San Juan Argentina
Novartis Investigative Site Natal Rio Grande do Norte
Novartis Investigative Site Ijuí Rio Grande do Sul
Novartis Investigative Site Florianópolis Santa Catarina
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Sao Jose Rio Preto Brazil
Novartis Investigative Site São Paulo Brazil
Novartis Investigative Site Chongqing Chongqing Municipality
Novartis Investigative Site Shijiazhuang Hebei
Novartis Investigative Site Harbin Heilongjiang
Novartis Investigative Site Changsha Hunan
Novartis Investigative Site Nanjing Jiangsu
Novartis Investigative Site Suzhou Jiangsu
Novartis Investigative Site Changchun Jilin
Novartis Investigative Site Kunming Yunnan
Novartis Investigative Site Hangzhou Zhejiang
Novartis Investigative Site Hangzhou Zhejiang
Novartis Investigative Site Beijing China
Novartis Investigative Site Qingdao China
Novartis Investigative Site Shanghai China
Novartis Investigative Site Shanghai China
Novartis Investigative Site Tianjin China
Novartis Investigative Site San José Costa Rica

+ 33 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05161195 on ClinicalTrials.gov ↗ ← All trials in India