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Ribociclib

Generic Name
Ribociclib
Brand Names
Kisqali 200 Mg Daily Dose Carton, Kisqali Femara Co-pack, Kisqali
Drug Type
Small Molecule
Chemical Formula
C23H30N8O
CAS Number
1211441-98-3
Unique Ingredient Identifier
TK8ERE8P56
Background

Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Ribociclib was approved by the U.S. FDA in March, 2017 as Kisqali.

Indication

用于联合芳香酶抑制剂或氟维司群治疗激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的晚期或转移性乳腺癌成人患者。

Associated Conditions
Advanced Breast Cancer, Metastatic Breast Cancer
Associated Therapies
-

Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases

Phase 1
Withdrawn
Conditions
Metastatic Breast Carcinoma
Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
Metastatic Malignant Neoplasm in the Brain
Prognostic Stage IV Breast Cancer AJCC v8
Interventions
First Posted Date
2020-10-14
Last Posted Date
2021-10-18
Lead Sponsor
Emory University
Registration Number
NCT04585724

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

Phase 2
Active, not recruiting
Conditions
Melanoma
Interventions
Drug: Ribociclib
Drug: Trametinib
Drug: LXH254
Drug: LTT462
First Posted Date
2020-06-04
Last Posted Date
2024-12-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
134
Registration Number
NCT04417621
Locations
🇺🇸

The Angeles Clinic and Research Institute, Los Angeles, California, United States

🇺🇸

Florida Cancer Specialists, Fort Myers, Florida, United States

🇺🇸

H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

and more 9 locations

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

Phase 1
Recruiting
Conditions
Metastatic Breast Cancer
Recurrent Ovarian Carcinoma
Interventions
First Posted Date
2020-03-19
Last Posted Date
2024-10-30
Lead Sponsor
University of Utah
Target Recruit Count
34
Registration Number
NCT04315233
Locations
🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

🇺🇸

Inova Schar Cancer Institute, Fairfax, Virginia, United States

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Phase 2
Terminated
Conditions
Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Interventions
First Posted Date
2020-02-05
Last Posted Date
2024-12-27
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
4
Registration Number
NCT04256941
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Ribociclib and Spartalizumab in R/M HNSCC

Phase 1
Active, not recruiting
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
First Posted Date
2019-12-30
Last Posted Date
2022-04-21
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
13
Registration Number
NCT04213404
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors.

First Posted Date
2019-10-04
Last Posted Date
2024-12-12
Lead Sponsor
Centre Leon Berard
Target Recruit Count
455
Registration Number
NCT04116541
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

Centre Léon Bérard, Lyon, France

🇫🇷

Institut Paoli Calmettes, Marseille, France

and more 5 locations

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Phase 1
Terminated
Conditions
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Gastrointestinal Stromal Tumors
Esophageal SCC
Non-small Cell Lung Carcinoma
Interventions
First Posted Date
2019-06-27
Last Posted Date
2024-11-22
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
122
Registration Number
NCT04000529
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇪🇸

Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain

A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer

Completed
Conditions
Breast Cancer
First Posted Date
2019-05-21
Last Posted Date
2024-08-09
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
78
Registration Number
NCT03956654
Locations
🇧🇪

UZ Gasthuisberg Leuven, Leuven, Belgium

FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Interventions
Drug: Ribociclib
Drug: Aromatase Inhibitors, non steroideal
Drug: LHRH agonist
First Posted Date
2019-05-09
Last Posted Date
2023-09-22
Lead Sponsor
Fondazione Sandro Pitigliani
Target Recruit Count
116
Registration Number
NCT03944434
Locations
🇮🇹

Hospital of Prato, Prato, Please select:, Italy

Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

Phase 3
Terminated
Conditions
Breast Cancer
Interventions
Drug: Ribociclib
Other: Mono-chemotherapy
Other: Endocrine-Therapy
First Posted Date
2019-04-05
Last Posted Date
2021-06-16
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
25
Registration Number
NCT03905343
Locations
🇧🇪

Grand Hôpital de Charleroi, Charleroi, Belgium

🇧🇪

Jessa Ziekenhuis, Hasselt, Belgium

🇨🇭

Brustzentrum Basel - Praxis für ambulante Tumortherapie, Basel, Switzerland

and more 31 locations
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