Ribociclib — Drug Intelligence | 45 EU Trials

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45 Registered trials

21 Recruiting

20 Completed trials

24 Sponsors

21 Countries

Phase III

Phase II

Phase I/II

Phase IV

Phase III: 15 Phase II: 12 Phase I/II: 7 Phase III/IV: 1 Phase IV: 7 Phase I (FiH): 3

Oversight events:

24 temporary halts 1 urgent safety measure 1 corrective measure across 7 trials

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Indications tested

Hormone receptor positive HER2 negative breast cancer 7 Breast cancer 6 Hormone receptor positive breast cancer 4 Breast cancer female 4 Breast cancer metastatic 2 Neoadjuvant therapy 1 Ovarian cancer recurrent 1 Colorectal cancer 1 Hormone receptor negative HER2 positive breast cancer 1 Metastatic malignant melanoma 1 Ovarian cancer 1 Medulloblastoma 1

Sponsors using this IMP

Novartis Pharma AG 9 F. Hoffmann-La Roche AG 5 AstraZeneca AB 4 Pfizer Inc. 3 Institut fuer Frauengesundheit GmbH 2 Medica Scientia Innovation Research S.L. 2 Solti Group 2 Unicancer 2 WSG Westdeutsche Studiengruppe GmbH 2 Amsterdam UMC Stichting 1 Blueprint Medicines Corp. 1 BOOG Study Center B.V. 1

All trials — page 2

45 total

A Study to Evaluate Efficacy and Safety of Multiple Treatment Combinations in Patients with Metastatic Breast Cancer (MORPHEUS-panBC) Recruiting

2023-503629-20-00 Phase I/II 3 countries F. Hoffmann-La Roche AG
Ribociclib in combination with endocrine therapy in patients with “estrogen receptor-positive and HER2-negative” breast cancer with high ris… Ended

2023-508827-10-00 Phase II 2 countries Solti Group
A Study to Test Inavolisib Treatments in Patients with Early-Stage, PIK3CA-Mutated Breast Cancer Ended

2024-518811-20-00 Phase II 2 countries F. Hoffmann-La Roche AG
A trial to learn more about the effects of ribociclib taken with endocrine therapy in patients with early breast cancer. Ended

2022-503001-38-01 Phase III 2 countries Novartis Pharma AG
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Letrozole in People Over 18 Years of Age With HR-Positive, … Ended

2024-512925-95-00 Phase III 16 countries Pfizer Inc.
TACTIVE-U: An Umbrella Study to Investigate the Safety and Antitumor Activity of ARV-471 in Combination With Other Medicines in Adults With … Ended

2022-502231-19-00 Phase I/II 2 countries Pfizer Inc.
Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies (FLOTILLA Study) Ended

2023-509408-13-00 Phase IV 9 countries Pfizer Inc.
A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsore… Ended

2024-514891-41-00 Phase IV 5 countries Novartis Pharma AG
A randomized, double-blind, Phase III Study of AZD9833 plus CDK4/6 inhibitor in patients with metastatic breast cancer with detectable ESR1 … Ended

2023-503990-39-00 Phase III 12 countries AstraZeneca AB
Phase Ib/III Study of Capivasertib + CDK4/6 Inhibitors + Fulvestrant as Treatment for Advanced/Metastatic HR+/HER2-Breast Cancer (CAPItello-… Ended

2023-504997-39-00 Phase III 8 countries AstraZeneca AB
Study of efficacy and safety of LXH254 combinations in patients with previously treated unresectable or metastatic melanoma Ended

2024-511934-11-00 Phase II 4 countries Novartis Pharma AG
Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate-risk… Ended

2024-515769-32-00 Phase III 1 country WSG Westdeutsche Studiengruppe GmbH
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant trea… Ended

2023-510357-42-00 Phase III 10 countries Novartis Pharma AG
Endocrine therapy plus CDK 4/6 inhibition in first- or second-line for hormone receptor positive advanced breast cancer - the SONIA study Ended

2024-516204-42-00 Phase III 1 country BOOG Study Center B.V.
An open-label, multi-center rollover protocol for patients who have participated in a Novartis-sponsored ribociclib (LEE011) study and are c… Ended

2024-511125-61-00 Phase I/II 2 countries Novartis Pharma AG
A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancer Ended

2023-509511-84-00 Phase I/II 2 countries Novartis Pharma AG
Phase I/II study to determine the safety and efficacy of Ribociclib in combination with hormone therapy and hypofractionated radiotherapy in… Ended

2022-501527-24-00 Phase I/II 1 country Centre Antoine Lacassagne
(VELA) Study of BLU-222 in Advanced Solid Tumors Ended

2022-502528-29-00 Phase I (FiH) 4 countries Blueprint Medicines Corp.
Detection of tumor DNA in the blood of patients receiving standard therapy for hormone receptorpositive (HR+) non-HER2 expressing (HER2-) me… Ended

2022-502372-22-01 Phase II 1 country Unicancer
Study to assess safety and identify dose of ribociclib in combination of temozolomide and topotecan (TOTEM) in patients (12 months – 21 year… Ended

2024-512095-35-00 Phase I/II 7 countries Novartis Pharma AG
Advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer Ended

2023-508828-35-01 Phase III 2 countries Solti Group

Showing 25–45 of 45 trials

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