Therapy Detail

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Therapy Name Everolimus + Ribociclib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Everolimus Afinitor RAD001|Zortress mTORC1 Inhibitor 9 Afinitor (everolimus) binds to FKBP-12 and allosterically inhibits mTOR, leading to decreased mTORC1 signaling and potentially resulting in decreased tumor cell growth (PMID: 17766661, PMID: 28400999). Afinitor (everolimus) is FDA approved for use in neuroendocrine tumors of pancreatic, lung or gastrointestinal tract origin, advanced renal cell carcinoma, in adult and pediatric patients aged 1 year and older with tuberous sclerosis complex who have subependymal giant cell astrocytoma, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (FDA.gov).
Ribociclib Kisqali LEE011 CDK4/6 Inhibitor 10 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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  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown high grade glioma not applicable Everolimus + Ribociclib Phase I Actionable In a Phase I trial, the combination treatment of Kisqali (ribociclib) and Afinitor (everolimus) did not result in any objective responses in pediatric patients with a malignant brain tumor (n=18) and led to 16 patients with disease progression, however, one patient had prolonged stable disease for 24 courses of treatment (PMID: 33547201; NCT03387020). 33547201
Unknown unknown pancreatic adenocarcinoma no benefit Everolimus + Ribociclib Phase I Actionable In a Phase I trial, treatment with the combination of Afinitor (everolimus) and Kisqali (ribociclib) did not lead to a clinical benefit in pancreatic adenocarcinoma patients who previously progressed on chemotherapy (n=11), resulting in a median progression-free survival of 1.8 months, a median overall survival of 3.7 months, stable disease in two patients for 8 weeks, and progressive disease in nine patients (PMID: 32642630; NCT02985125). 32642630

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03387020 Phase I Ribociclib Everolimus + Ribociclib Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors Completed USA 0
NCT03070301 Phase II Everolimus + Ribociclib A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors Active, not recruiting USA 0
NCT03834740 Phase I Everolimus + Ribociclib A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection Recruiting USA 0
NCT02985125 Phase Ib/II Everolimus + Ribociclib LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy Active, not recruiting USA 0
NCT03355794 Phase I Everolimus + Ribociclib A Study of Ribociclib and Everolimus 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 USA 0
NCT03114527 Phase II Everolimus + Ribociclib Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) Recruiting USA 0


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