- Trials with a EudraCT protocol (33)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
33 result(s) found for: Ribociclib.
Displaying page 1 of 2.
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 | |||||||||||||
|
|||||||||||||
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 | |||||||||||||
|
|||||||||||||
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 | |||||||||||||
|
|||||||||||||
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 | |||||||||||||
|
|||||||||||||
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 | ||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||
|
|||||||||||||||||||||||
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 | ||||||||||||||||||
|
||||||||||||||||||
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 | ||||||||||||||||||
|
||||||||||||||||||
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 | |||||||||||||
|
|||||||||||||
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 . | ||||||||||||||||||
|
||||||||||||||||||
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 | ||||||||||||||||||
|
||||||||||||||||||
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 | |||||||||||||
|
|||||||||||||
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 | ||||||||||||||||||
|
||||||||||||||||||
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 |
Subscribe to this Search
To subscribe to the RSS feed for this search click here
.
This will provide an RSS feed for clinical trials matching your search that have been added or updated in the last 7 days.
To subscribe to the RSS feed for this search click here

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. |
