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|LEE-011|LEE 011 | CDK4/6 Inhibitor 14 | 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 |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03114527 | Phase II | Everolimus + Ribociclib | Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) | Active, not recruiting | USA | 0 |
| NCT03387020 | Phase I | Ribociclib Everolimus + Ribociclib | Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors | Completed | USA | 0 |
| NCT05843253 | Phase II | Everolimus + Ribociclib | Study of Ribociclib and Everolimus in HGG and DIPG | Recruiting | USA | NLD | GBR | DEU | CAN | AUS | 0 |
| NCT03070301 | Phase II | Everolimus + Ribociclib | A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors | Completed | 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) | Completed | 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 | Completed | USA | 0 |
| NCT02985125 | Phase Ib/II | Everolimus + Ribociclib | LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy | Unknown status | USA | 0 |
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