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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). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Ribociclib | Kisqali | LEE011 | CDK4/6 Inhibitor 12 | 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 |
---|---|---|---|---|---|---|---|
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 |
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 |
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 |
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 |
NRAS Q61K PIK3CA E545K | melanoma | predicted - sensitive | Ribociclib | Preclinical - Cell culture | Actionable | In a preclinical study, a melanoma cell line harboring NRAS Q61K and expressing PIK3CA E545K was resistant to treatment with Kisqali (ribociclib) in culture (PMID: 29496665). | 29496665 |
NRAS Q61L PIK3CA E545K | melanoma | predicted - resistant | Ribociclib | Preclinical - Cell culture | Actionable | In a preclinical study, a melanoma cell line harboring NRAS Q61L and expressing PIK3CA E545K was resistant to treatment with Kisqali (ribociclib) in culture (PMID: 29496665). | 29496665 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
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 | ITA | ESP | 10 |
NCT03078751 | Phase II | Ribociclib | Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1) | Completed | USA | 0 |
NCT02934568 | Phase II | Ribociclib | Ribociclib (LEE011) Rollover Study for Continued Access | Active, not recruiting | USA | FRA | ESP | 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 | |
NCT03179956 | Phase I | Ribociclib | Impact of Ribociclib on Head and Neck Squamous Cell Cancer | Terminated | 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 |
NCT01237236 | Phase I | Ribociclib | A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma. | Completed | USA | FRA | 1 |
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 |
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 |
NCT02345824 | Phase I | Ribociclib | Early-Phase Study to Assess Inhibitor LEE011 in Patients With Recurrent Glioblastoma or Anaplastic Glioma | Unknown status | USA | 0 |
NCT02187783 | Phase II | Ribociclib | LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) | Completed | USA | 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) | Recruiting | DEU | 0 |
NCT02420691 | Phase II | Ribociclib | LEE011 in Neuroendocrine Tumors of Foregut Origin | Completed | USA | 0 |
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 |
NCT03285412 | Phase II | Ribociclib | CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer | Recruiting | 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 |
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 |
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 | |
NCT04055493 | Phase III | Ribociclib | Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (ADAPTcycle) | Recruiting | DEU | 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 | 7 |
NCT02933736 | Phase 0 | Ribociclib | Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients | Recruiting | USA | 0 |
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 |
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 |