Therapy Detail

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Therapy Name Ribociclib
Synonyms
Therapy Description

Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ribociclib Kisqali LEE011 CDK4/6 Inhibitor 11 Kisqali (ribociclib) is a dual CDK4/6 inhibitor, which may induce cell cycle arrest and reduce proliferation in cancer cells (PMID: 24045179). Kisqali (ribociclib) is FDA-approved in combination with an aromatase inhibitor in women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer, and in combination with Faslodex (fulvestrant) in postmenopausal women with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CDKN2A del RB1 pos glioblastoma predicted - sensitive Ribociclib Phase 0 Actionable In a Phase 0 trial, Kisqali (ribociclib) demonstrated good CNS penetration and inhibited Rb1 phosphorylation and tumor cell proliferation, resulted in a median progression-free survival of 9.7 weeks and a median overall survival of 7.8 months in patients (n=6) with recurrent glioblastoma with intact Rb1 expression and harboring deletion of CDKN2A or amplification of CDK4 or CDK6 (PMID: 31285369; NCT02933736). 31285369
PTEN loss breast cancer predicted - resistant Ribociclib Preclinical - Cell culture Actionable In a preclinical study, treatment with Kisqali (ribociclib) resulted in a decreased response in two PTEN-deficient breast cancer cell lines in culture compared to control cells and resistance in a cell-line xenograft model (PMID: 31594766). 31594766
PIK3CA H1047R oral squamous cell carcinoma decreased response Ribociclib Preclinical - Cell culture Actionable In a preclinical study, oral squamous cell carcinoma cells expressing PIK3CA H1047R demonstrated reduced sensitivity to Kisqali (ribociclib) treatment compared to cells expressing wild-type PIK3CA in culture (PMID: 31516747). 31516747
RB1 positive Advanced Solid Tumor predicted - sensitive Ribociclib Phase I Actionable In a Phase I clinical trial, Kisqali (ribociclib) demonstrated safety and preliminary efficacy in patients with RB1-positive solid tumors and lymphomas, resulting in partial responses in 2.3% (3/132) of patients and stable disease in 32.6% (41/132) of patients, including 8 patients demonstrating stable disease for greater than 6 months (PMID: 27542767, PMID: 24795392). detail... 24795392 27542767

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03078751 Phase II Ribociclib Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1) Completed USA 0
NCT04055493 Phase III Ribociclib Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (ADAPTcycle) Recruiting DEU 0
NCT02187783 Phase II Ribociclib LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) Completed USA 0
NCT03179956 Phase I Ribociclib Impact of Ribociclib on Head and Neck Squamous Cell Cancer Terminated USA 0
NCT01747876 Phase I Ribociclib Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma Terminated USA | FRA | DEU 2
NCT02933736 Phase 0 Ribociclib Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients Recruiting USA 0
NCT03477396 Phase II Ribociclib Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer Active, not recruiting USA 0
NCT02345824 Phase I Ribociclib Early-Phase Study to Assess Inhibitor LEE011 in Patients With Recurrent Glioblastoma or Anaplastic Glioma Unknown status USA 0
NCT02657343 Phase Ib/II Ribociclib Trastuzumab Ado-trastuzumab emtansine An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer. Completed USA 0
NCT02420691 Phase II Ribociclib LEE011 in Neuroendocrine Tumors of Foregut Origin Completed USA 0
NCT04417621 Phase II LTT462 + LXH 254 Trametinib Ribociclib Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma Active, not recruiting USA | ITA | FRA | DEU | BEL | AUT 7
NCT05161195 FDA approved Fulvestrant + Ribociclib Ribociclib Ribociclib + Tamoxifen Goserelin + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib Roll-over Study to Allow Continued Access to Ribociclib Recruiting USA 2
NCT04801966 Phase 0 Palbociclib Alpelisib Atezolizumab Vemurafenib Ribociclib Talazoparib Cobimetinib Trametinib Abemaciclib Dabrafenib Nivolumab Binimetinib Pembrolizumab Encorafenib Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study (TAILOR) Recruiting 1
NCT03701334 Phase III Ribociclib A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT02607124 Phase Ib/II Ribociclib Administration of Ribociclib Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG) Terminated USA 0
NCT03387020 Phase I Ribociclib Everolimus + Ribociclib Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors Completed USA 0
NCT05296746 Phase II Ribociclib Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer (RIBOLARIS) Recruiting FRA | ESP 1
NCT02555189 Phase Ib/II Ribociclib Enzalutamide Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression Recruiting USA 0
NCT01237236 Phase I Ribociclib A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma. Completed USA | FRA 1
NCT03285412 Phase II Ribociclib CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer Recruiting USA 0
NCT02934568 Phase II Ribociclib Ribociclib (LEE011) Rollover Study for Continued Access Recruiting USA | FRA | ESP 2
NCT02300987 Phase II Ribociclib A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression Completed USA | FRA | ESP 1
NCT04585724 Phase I Abemaciclib Palbociclib Ribociclib Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases Withdrawn 0
NCT05452213 FDA approved Ribociclib Comprehensive Analysis of Spatial, Temporal and Molecular Patters of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients (CAPTOR-BC) Not yet recruiting DEU 0
NCT02035813 Phase II Ribociclib Eribulin DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). Active, not recruiting DEU 0
NCT02524119 Phase II Ribociclib LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001) Terminated USA 0


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