Therapy Detail

Therapy Name Ribociclib
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 8 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
NOTCH1 wild-type RB1 wild-type T-cell adult acute lymphocytic leukemia sensitive Ribociclib Preclinical - Cell culture Actionable In a preclinical study, a T-cell acute lymphoblastic leukemia cell line harboring wild-type RB1 and wild-type NOTCH1 demonstrated sensitivity to treatment with Kisqali (ribociclib) in culture, resulting in inhibition of cell growth (PMID: 28151717). 28151717
Unknown unknown rhabdoid cancer not applicable Ribociclib Phase I Actionable In a Phase I trial, Kisqali (ribociclib) treatment demonstrated safety and resulted in stable disease in 28% (9/32) of pediatric patients with neuroblastoma or malignant rhabdoid tumor (MRT) (7 patients with neuroblastoma and 2 with CNS primary MRT), and 5 patients demonstrated stable disease for greater than 6 months (PMID: 28432176). 28432176
NOTCH1 wild-type RB1 loss T-cell adult acute lymphocytic leukemia resistant Ribociclib Preclinical - Cell culture Actionable In a preclinical study, a T-cell acute lymphoblastic leukemia cell line harboring wild-type NOTCH1 and loss of RB1 demonstrated resistance to Kisqali (ribociclib) in culture, resulting in limited inhibition of cell growth (PMID: 28151717). 28151717
Unknown unknown neuroblastoma not applicable Ribociclib Phase I Actionable In a Phase I trial, Kisqali (ribociclib) treatment demonstrated safety and resulted in stable disease in 28% (9/32) of pediatric patients with neuroblastoma or malignant rhabdoid tumor (MRT) (7 patients with neuroblastoma and 2 with CNS primary MRT), and 5 patients demonstrated stable disease for greater than 6 months (PMID: 28432176). 28432176
NOTCH1 mut RB1 wild-type T-cell adult acute lymphocytic leukemia sensitive Ribociclib Preclinical - Cell culture Actionable In a preclinical study, a T-cell acute lymphoblastic leukemia cell line co-harboring wild-type RB1 and a NOTCH1 mutation demonstrated sensitivity to treatment with Kisqali (ribociclib) in culture, resulting in inhibition of cell growth (PMID: 28151717). 28151717
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). detail... 24795392 27542767
Clinical Trial Phase Therapies Title Recruitment Status
NCT03477396 Phase II Ribociclib Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer Active, not recruiting
NCT02524119 Phase II Ribociclib LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001) Recruiting
NCT01237236 Phase I Ribociclib A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma. Completed
NCT03434262 Phase I Filgrastim + Gemcitabine + Pegfilgrastim + Ribociclib Trametinib Sonidegib Ribociclib Ribociclib + Trametinib Ribociclib + Sonidegib Molecularly-Driven Doublet Therapy for Recurrent CNS Malignant Neoplasms Recruiting
NCT02555189 Phase Ib/II Ribociclib Enzalutamide Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression Recruiting
NCT01747876 Phase I Ribociclib Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma Completed
NCT03285412 Ribociclib CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer Recruiting
NCT02657343 Phase Ib/II Ribociclib Trastuzumab 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. Recruiting
NCT02933736 Phase 0 Ribociclib Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients Recruiting
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) Active, not recruiting
NCT02345824 Phase I Ribociclib Early-Phase Study to Assess Inhibitor LEE011 in Patients With Recurrent Glioblastoma or Anaplastic Glioma Active, not recruiting
NCT02632045 Phase II Fulvestrant Ribociclib Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ H2N- Advanced Breast Cancer Recruiting
NCT02420691 Phase II Ribociclib LEE011 in Neuroendocrine Tumors of Foregut Origin Active, not recruiting
NCT03078751 Phase III Ribociclib Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1) Active, not recruiting
NCT02934568 Phase II Ribociclib Ribociclib (LEE011) Rollover Study for Continued Access Active, not recruiting
NCT03387020 Phase I Ribociclib Ribociclib + Everolimus Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors Recruiting
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) Recruiting
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
NCT03179956 Phase I Ribociclib Impact of Ribociclib on Head and Neck Squamous Cell Cancer Recruiting
NCT02422615 Phase III Ribociclib Fulvestrant Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer. Active, not recruiting
NCT02187783 Phase II Ribociclib LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) Completed
NCT02278120 Phase III Tamoxifen Letrozole Ribociclib Goserelin Anastrozole Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Active, not recruiting
NCT01958021 Phase III Ribociclib Letrozole Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) Active, not recruiting