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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: LEE011 Clear all
Terminated Phase 1 Interventional

A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

NCT02974725
View directory record Official record
Conditions
Non-Small Cell Lung Cancer, Melanoma
Interventions
LXH254, LTT462, Trametinib, Ribociclib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
241 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
6
States / cities
San Diego, California • San Francisco, California • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2025 · Synced Sep 17, 2026, 8:30 PM EDT
Active, not recruiting Phase 1 Interventional

Study of INCB123667 in Subjects With Advanced Solid Tumors

NCT05238922
View directory record Official record
Conditions
Solid Tumors
Interventions
INCB0123667, Palbociclib, Bevacizumab, Olaparib, Paclitaxel, Ribociclib, Fulvestrant
Drug
Lead sponsor
Incyte Corporation
Industry
Eligibility
18 Years and older
Enrollment
291 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
18
States / cities
Duarte, California • Irvine, California • Los Angeles, California + 13 more
Source: ClinicalTrials.gov public record
Updated Jul 20, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Completed No phase listed Observational

Emulation of the MONALEESA-2 Trial Using Specialty Oncology Electronic Health Records Databases

NCT07274709
View directory record Official record
Conditions
Advanced Breast Cancer
Interventions
Initiation of ribociclib, Initiation of letrozole
Drug
Lead sponsor
Shirley Vichy Wang
Other
Eligibility
18 Years and older · Female only
Enrollment
2,495 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 11, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Completed Phase 2 Interventional Results available

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

NCT02187783
View directory record Official record
Conditions
Tumors With CDK4/6 Pathway Activation
Interventions
LEE011
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
106 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
61
States / cities
Birmingham, Alabama • Anchorage, Alaska • Phoenix, Arizona + 53 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2019 · Synced Sep 17, 2026, 8:30 PM EDT
Terminated Phase 1 Interventional

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

NCT05384119
View directory record Official record
Conditions
Breast Cancer
Interventions
TTI-101, Palbociclib, Aromatase inhibitor (AI), fulvestrant, ribociclib
Drug
Lead sponsor
Tvardi Therapeutics, Incorporated
Industry
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
6
States / cities
Fort Lauderdale, Florida • St Louis, Missouri • Nashville, Tennessee + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 20, 2025 · Synced Sep 17, 2026, 8:30 PM EDT
Recruiting Phase 3 Interventional

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

NCT07085767
View directory record Official record
Conditions
Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
Interventions
Palazestrant, Letrozole-matching placebo, Ribociclib, Letrozole, Palazestrant matching-placebo
Drug
Lead sponsor
Olema Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2032
U.S. locations
47
States / cities
Hot Springs, Arkansas • Beverly Hills, California • La Jolla, California + 44 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Terminated Phase 2 Interventional Results available

LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma

NCT02524119
View directory record Official record
Conditions
Hepatocellular Carcinoma
Interventions
LEE011, Chemoembolization
Drug · Procedure
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jan 31, 2021 · Synced Sep 17, 2026, 8:30 PM EDT
Completed Early Phase 1 Interventional Results available

A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection

NCT03834740
View directory record Official record
Conditions
Glioblastoma Multiforme, Glioma of Brain
Interventions
Ribociclib, Everolimus
Drug
Lead sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Other
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
3
States / cities
Chandler, Arizona • Phoenix, Arizona • Scottsdale, Arizona
Source: ClinicalTrials.gov public record
Updated May 29, 2025 · Synced Sep 17, 2026, 8:30 PM EDT
Active, not recruiting Phase 2 Interventional Results available

Ribociclib and Letrozole Treatment in Ovarian Cancer

NCT03673124
View directory record Official record
Conditions
Low Grade Serous Carcinoma
Interventions
Ribociclib, Letrozole
Drug
Lead sponsor
Gynecologic Oncology Group
Network
Eligibility
18 Years and older · Female only
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
27
States / cities
San Francisco, California • Gainesville, Florida • Tampa, Florida + 19 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 17, 2026, 8:30 PM EDT
Recruiting Phase 4 Interventional

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

NCT05203172
View directory record Official record
Conditions
Solid Tumors
Interventions
Binimetinib only treatment, Encorafenib only Treatment, Encorafenib & Binimetinib Treatment, Treatment of Encorafenib & Binimetinib & Ribociclib, Treatment of Encorafenib & Binimetinib & Cetuximab
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2029
U.S. locations
18
States / cities
Phoenix, Arizona • Atlanta, Georgia • Boston, Massachusetts + 5 more
Source: ClinicalTrials.gov public record
Updated Apr 6, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Terminated Phase 1 Interventional

Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

NCT05429502
View directory record Official record
Conditions
Neuroblastoma
Interventions
Topotecan, Temozolomide, Ribociclib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Months to 21 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
3
States / cities
Boston, Massachusetts • New Hyde Park, New York • Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Oct 9, 2025 · Synced Sep 17, 2026, 8:30 PM EDT
Completed Phase 1 Interventional Results available

TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer

NCT02586675
View directory record Official record
Conditions
Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
Interventions
Tamoxifen, Ribociclib, Goserelin
Drug
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Jan 20, 2022 · Synced Sep 17, 2026, 8:30 PM EDT
Completed Phase 1 Interventional

Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

NCT03237390
View directory record Official record
Conditions
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Interventions
Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Ribociclib
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
3
States / cities
Phoenix, Arizona • Jacksonville, Florida • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Jan 4, 2023 · Synced Sep 17, 2026, 8:30 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

NCT05563220
View directory record Official record
Conditions
Breast Cancer, Metastatic Breast Cancer
Interventions
Elacestrant, Alpelisib, Everolimus, Ribociclib, Palbociclib, Capivasertib, Abemaciclib
Drug
Lead sponsor
Stemline Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
435 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
35
States / cities
Dothan, Alabama • Phoenix, Arizona • Springdale, Arkansas + 30 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Recruiting Phase 2 Interventional

Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy

NCT06953882
View directory record Official record
Conditions
HER2 Negative Breast Cancer
Interventions
Ribociclib 400mg, Letrozole 2.5mg, Anastrazole 1mg, Goserelin 3.6 MG, Adjuvant chemotherapy
Drug · Radiation
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated May 25, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Completed Phase 3 Interventional Results available

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

NCT02422615
View directory record Official record
Conditions
Advanced Breast Cancer
Interventions
Ribociclib, Fulvestrant, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
726 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2023
U.S. locations
26
States / cities
Mobile, Alabama • Chandler, Arizona • Fayetteville, Arkansas + 22 more
Source: ClinicalTrials.gov public record
Updated Nov 29, 2023 · Synced Sep 17, 2026, 8:30 PM EDT
Completed Phase 1 Interventional

Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.

NCT02154776
View directory record Official record
Conditions
Advanced or Metastatic Breast Cancer
Interventions
LEE011, Buparlisib, Letrozole
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
5
States / cities
Los Angeles, California • Lafayette, Indiana • Charleston, South Carolina + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 17, 2026, 8:30 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011

NCT02388620
View directory record Official record
Conditions
Normal Hepatic Function, Impaired Hepatic Function
Interventions
LEE011
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
3
States / cities
Anaheim, California • Coral Gables, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 17, 2026, 8:30 PM EDT
Recruiting Phase 2 Interventional

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

NCT05843253
View directory record Official record
Conditions
High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Glioblastoma, Glioblastoma Multiforme, Diffuse Midline Glioma, H3 K27M-Mutant, Metastatic Brain Tumor, WHO Grade III Glioma, WHO Grade IV Glioma, Diffuse Hemispheric Glioma, H3 G34-Mutant
Interventions
Ribociclib, Everolimus, Temozolomide (TMZ)
Drug
Lead sponsor
Nationwide Children's Hospital
Other
Eligibility
12 Months to 39 Years
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2034
U.S. locations
11
States / cities
Aurora, Colorado • Washington D.C., District of Columbia • Chicago, Illinois + 8 more
Source: ClinicalTrials.gov public record
Updated May 28, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Active, not recruiting Phase 2 Interventional

Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

NCT04417621
View directory record Official record
Conditions
Melanoma
Interventions
LXH254, LTT462, Trametinib, Ribociclib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 120 Years
Enrollment
134 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
12
States / cities
Los Angeles, California • San Francisco, California • Fort Myers, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Mar 11, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Active, not recruiting Phase 3 Interventional

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

NCT06065748
View directory record Official record
Conditions
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Interventions
Giredestrant, Fulvestrant, Abemaciclib, Palbociclib, Ribociclib, LHRH Agonist, FoundationOne Liquid CDx Assay (F1LCDx)
Drug · Diagnostic Test
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
1,050 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
40
States / cities
Daphne, Alabama • Greenbrae, California • Harbor City, California + 34 more
Source: ClinicalTrials.gov public record
Updated Sep 13, 2026 · Synced Sep 17, 2026, 8:30 PM EDT
Terminated Phase 1 Interventional

Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer

NCT03294694
View directory record Official record
Conditions
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer, Metastatic Epithelial Ovarian Cancer
Interventions
Ribociclib, PDR001, Fulvestrant
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
3
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Sep 17, 2026, 8:30 PM EDT
Completed No phase listed Observational

A Study of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer

NCT07086196
View directory record Official record
Conditions
Metastatic HR+/HER2- Breast Cancer
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Jul 24, 2025 · Synced Sep 17, 2026, 8:30 PM EDT
Terminated Phase 1 Interventional

Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

NCT02703571
View directory record Official record
Conditions
Solid Tumors for Phase Ib, Pancreatic Cancer for Phase II, Colorectal Cancer for Phase II
Interventions
ribociclib, Trametinib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
95 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
6
States / cities
Fayetteville, Arkansas • Duarte, California • New Haven, Connecticut + 3 more
Source: ClinicalTrials.gov public record
Updated Dec 20, 2020 · Synced Sep 17, 2026, 8:30 PM EDT