Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Ribociclib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43395   clinical trials with a EudraCT protocol, of which   7179   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    33 result(s) found for: Ribociclib. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-000293-37 Sponsor Protocol Number: CLEE011X2X01B Start Date*: 2016-12-05
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: An open-label, multi-center rollover protocol for patients who have participated in a Novartis-sponsored ribociclib (LEE011) study and are continuing to benefit from ribociclib as single agent or i...
    Medical condition: different types of advanced cancer
    Disease:
    Population Age: Children, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005617-14 Sponsor Protocol Number: CLEE011Q12101 Start Date*: 2022-10-10
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: Phase I/II multicenter study to assess efficacy and safety of ribociclib (LEE011) in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory neuroblast...
    Medical condition: relapsed or refractory neuroblastoma and other solid tumors (including medulloblastoma, high grade glioma, malignant rhabdoid tumors, and rhabdomyosarcoma) in patients from 12 months to 21 years old
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Ongoing) CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003467-19 Sponsor Protocol Number: CLEE011A2404 Start Date*: 2016-12-08
    Sponsor Name:Novartis Pharma AG
    Full Title: COMPLEEMENT-1: An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal wo...
    Medical condition: hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) HU (Completed) BG (Completed) PT (Completed) GR (Completed) SK (Completed) IT (Completed) CZ (Completed) AT (Completed) ES (Ongoing) DK (Completed) NO (Completed) PL (Completed) FI (Completed) SI (Completed) RO (Ongoing) LU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002514-12 Sponsor Protocol Number: FACILE Start Date*: 2019-11-12
    Sponsor Name:FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI - ONLUS
    Full Title: Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in elderly patients with hormone receptor positive...
    Medical condition: HR+, HER2 negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002556-24 Sponsor Protocol Number: CLEE011XDE01 Start Date*: 2016-10-14
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A national phase IIIb, multi-center, open label study for women and men with hormone-receptor positive, HER2-negative locally advanced or metastatic breast cancer treated with ribociclib (LEE011) i...
    Medical condition: HR+, HER2- advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000617-43 Sponsor Protocol Number: CLEE011F2301 Start Date*: 2015-05-27
    Sponsor Name:Novartis Pharma Services AG
    Full Title: MONALEESA-3: A randomized double-blind, placebo-controlled study of ribociclib in combination with fulvestrant for the treatment of men and postmenopausal women with hormone receptor positive, HER2...
    Medical condition: men and postmenopausal women with HR+, HER2-negative advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) AT (Completed) ES (Ongoing) CZ (Completed) DK (Completed) NL (Completed) HU (Completed) BE (Completed) BG (Completed) FR (Completed) PT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002322-24 Sponsor Protocol Number: SOLTI-1911 Start Date*: 2022-03-10
    Sponsor Name:SOLTI
    Full Title: Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS)
    Medical condition: Patients with primary operable stage II, grade 2 or 3, Ki67 ≥20%, HR+/HER2- breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to n...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004234-15 Sponsor Protocol Number: CLEE011A2207 Start Date*: 2019-05-24
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400 mg of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre- an...
    Medical condition: HR-positive, HER2-negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    23.0 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    21.1 100000004864 10072737 Advanced breast cancer LLT
    20.0 100000004864 10073289 Premenopausal breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Ongoing) SE (Ongoing) CZ (Ongoing) FR (Ongoing) LT (Ongoing) AT (Ongoing) FI (Ongoing) DE (Restarted) PT (Ongoing) HU (Ongoing) BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005019-34 Sponsor Protocol Number: CTMT212X2106 Start Date*: 2016-05-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase I/II study of safety and efficacy of ribociclib (LEE011) in combination with trametinib (TMT212) in patients with metastatic or advanced solid tumors
    Medical condition: Solid tumors, Pancreatic Cancer, Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049280 Solid tumour LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033604 Pancreatic cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002998-21 Sponsor Protocol Number: CLEE011O12301C Start Date*: 2019-02-25
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, multicenter, randomized, open-label trial toevaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-...
    Medical condition: hormone receptor-positive, HER2-negative, early breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006203 Breast cancer stage unspecified LLT
    23.0 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) IE (Ongoing) HU (Ongoing) AT (Ongoing) BE (Ongoing) DE (Restarted) FR (Ongoing) PL (Ongoing) IT (Ongoing) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002027-38 Sponsor Protocol Number: SOLTI-2101 Start Date*: 2022-02-11
    Sponsor Name:SOLTI
    Full Title: A Phase III, multicenter, open-label study of ribociclib vs. palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA trial
    Medical condition: Patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003667-35 Sponsor Protocol Number: GBG-97-AMICA Start Date*: 2017-12-29
    Sponsor Name:GBG Forschungs GmbH
    Full Title: Anti-hormonal maintenance treatment with the CDK4/6 inhibitor Ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial
    Medical condition: HR-positive/HER2-negative metastatic breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003098-17 Sponsor Protocol Number: SOLTI-1402 Start Date*: 2017-03-29
    Sponsor Name:SOLTI
    Full Title: CORALLEEN: A Phase 2 Clinical Trial of multi-agent Chemotherapy or letrozole plus Ribociclib (LEE001) as neoadjuvant treatment for postmenopausal patients with Luminal B/HER2-negative breast cancer.
    Medical condition: Luminal B/HER2-negative breast cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-005184-42 Sponsor Protocol Number: CLEE011A2412B Start Date*: 2022-04-15
    Sponsor Name:NOVARTIS PHARMA AG
    Full 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
    Medical condition: HR+, HER2- advanced or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) ES (Ongoing) PL (Ongoing) PT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001269-18 Sponsor Protocol Number: D-IVa/D-IVb Start Date*: 2013-12-19
    Sponsor Name:Universitätsklinikum Ulm (AöR)
    Full Title: A multicenter phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs).
    Medical condition: Everolimus/ribociclib cohort (D-IVa): Postmenopausal female patients with hormone-receptor positive, HER2-negative metastatic breast cancer with HER2-negative circulating tumor cells (CTCs) and ind...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004176-62 Sponsor Protocol Number: CLEE011AIT01 Start Date*: 2018-01-10
    Sponsor Name:NOVARTIS FARMA S.P.A.
    Full Title: A phase IIIb, open-label, local, multicenter study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatmen...
    Medical condition: Hormone receptor-positive (HR+) HER2-negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003648-22 Sponsor Protocol Number: SAKK_2118 Start Date*: 2020-02-26
    Sponsor Name:SAKK
    Full Title: Ribociclib-endocrine combination therapy versus chemotherapy as 1st line treatment in patients with visceral metastatic breast cancer. A multicenter, randomized phase III trial.
    Medical condition: Histologically or cytologically confirmed diagnosis of HR-positive, HER2-negative advanced stage breast cancer with measurable visceral metastases .
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    20.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000873-26 Sponsor Protocol Number: CLXH254C12201 Start Date*: 2020-11-02
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, open-label, multi-arm, two-part, phase II study to assess the efficacy and safety of multiple LXH254 combinations in patients with previously treated unresectable or metastatic BRAFV6...
    Medical condition: previously treated unresectable or metastatic BRAFV600 or NRAS mutant melanoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027480 Metastatic malignant melanoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027150 Melanoma malignant LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Temporarily Halted) GB (GB - no longer in EU/EEA) DE (Temporarily Halted) FR (Ongoing) AT (Completed) NL (Ongoing) PL (Completed) BE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000676-29 Sponsor Protocol Number: BOOG-2017-01 Start Date*: 2018-01-12
    Sponsor Name:BOOG Study Center
    Full Title: Tailoring neoadjuvant therapy in hormone receptor positive, HER2 negative, luminal breast cancer.
    Medical condition: Mamma carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001795-53 Sponsor Protocol Number: CLEE011G2301 Start Date*: 2017-11-02
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone r...
    Medical condition: Hormone receptor-positive, Estrogen and/or progesterone receptor-positive, HER2-negative, High risk early breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020819 10006203 Breast cancer stage unspecified LLT
    20.0 100000115074 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Prematurely Ended) BE (Completed) NL (Prematurely Ended) GR (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA