Clinical trials: Ribociclib
Locally Advanced or Metastatic NRAS Mutant Melanoma
A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma
In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination.
- Trial name
- NCT01781572
- Testing
- LEE011, MEK162
- Where
- 17 sites in United States, Australia and 3 more
- Volunteers
- 102 people
- Sponsor
- Pfizer
Malignant Rhabdoid Tumors (MRT), Neuroblastoma
Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma
LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended…
- Trial name
- NCT01747876
- Testing
- LEE011
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Breast Cancer - Female
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women…
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Trial name
- NCT02586675
- Testing
- Tamoxifen, Ribociclib, Goserelin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Tumors With CDK4/6 Pathway Activation
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.
- Trial name
- SIGNATURE (NCT02187783)
- Testing
- LEE011
- Where
- 61 sites in United States
- Volunteers
- 106 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Trial name
- RIGHT Choice (NCT03839823)
- Testing
- Docetaxel / Capecitabine, Capecitabine / Vinorelbine, Paclitaxel / Gemcitabine
- Where
- 50 sites in Egypt, India and 11 more
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Metastatic Breast Cancer
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic)…
- Trial name
- NCT03096847
- Testing
- ribociclib, letrozole, goserelin
- Where
- 84 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma
Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression
This phase Ib/II trial studies the safety, side effects, best dose, and effectiveness of ribociclib when given with enzalutamide in treating patients with castrate-resistant prostate cancer that has spread from the primary site…
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer AJCC v7
- Trial name
- NCT02555189
- Testing
- Enzalutamide, Ribociclib, Laboratory Biomarker Analysis
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma
Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors
This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment.
- Conditions
- CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma, Recurrent Atypical Teratoid/Rhabdoid Tumor, Recurrent Childhood Ependymoma
- Trial name
- NCT03387020
- Testing
- Everolimus, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 12 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pediatric Brain Tumor Consortium
Early Breast Cancer
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
- Trial name
- MONALEESA-1 (NCT01919229)
- Testing
- LEE011 (ribociclib), letrozole
- Where
- 7 sites in United States, Singapore and 1 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced Metastatic BRAF Mutant Melanoma
Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.
To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
- Trial name
- NCT01777776
- Testing
- LEE011, LGX818
- Where
- 9 sites in United States, Australia and 2 more
- Volunteers
- 28 people
- Sponsor
- Array BioPharma
Metastatic Breast Cancer, Breast Carcinoma
Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer
This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor…
- Trial name
- MAINTAIN (NCT02632045)
- Testing
- LEE-011, Fulvestrant
- Where
- 13 sites in United States
- Volunteers
- 169 people
- Sponsor
- Melissa K Accordino
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0…
- Trial name
- FELINE (NCT02712723)
- Testing
- Letrozole, Ribociclib
- Where
- 13 sites in United States
- Volunteers
- 121 people
- Sponsor
- Qamar Khan
Melanoma
LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the…
- Trial name
- LOGIC-2 (NCT02159066)
- Testing
- LGX818, MEK162, LEE011
- Where
- 32 sites in United States, Australia and 7 more
- Volunteers
- 158 people
- Sponsor
- Pfizer
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
Glioblastoma Multiforme, Glioma of Brain
A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection
In the proposed trial, patients will be administered ribociclib+everolimus prior to surgical resection of their tumor. Recurrent GBM patients will be randomized into one of the three time-interval cohorts for the first two dose…
- Trial name
- NCT03834740
- Testing
- Ribociclib, Everolimus
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
Breast Cancer
Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African American/Blacks and Non-Hispanic White patients.
- Trial name
- LEANORA (NCT04657679)
- Testing
- Ribociclib
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Georgetown University
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, Recurrent Ovarian Carcinoma
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
This is an open-label, multi-center, phase I study designed to assess the maximum tolerated dose of ribociclib and belinostat in combination.
- Trial name
- CHARGE (NCT04315233)
- Testing
- Ribociclib, Belinostat
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Utah