Therapy Detail

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Therapy Name LY3023414
Synonyms
Therapy Description

LY3023414 is an ATP competitive inhibitor of PI3K/mTOR, inhibits signaling of the PI3K/mTOR pathway, and has demonstrated antiproliferative activity against tumor cells (PMID: 24387334).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
LY3023414 Samotolisib|LY-3023414|LY 3023414 mTOR Inhibitor 51 PI3K Inhibitor (Pan) 37 Samotolisib (LY3023414) is an ATP competitive inhibitor of PI3K/mTOR, inhibits signaling of the PI3K/mTOR pathway, and has demonstrated antiproliferative activity against tumor cells (PMID: 24387334, PMID: 31880826).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA E545K leukemia sensitive LY3023414 Preclinical Actionable In a preclinical study, LY3023414 inhibited tumor growth in a transgenic animal model of leukemia driven by PIK3CA E545K (PMID: 27439478). 27439478
Unknown unknown endometrial cancer not applicable LY3023414 Phase II Actionable In a Phase II trial, patients with advanced endometrial cancer harboring a PI3K pathway mutation demonstrated a best overall response rate of 16% (4/25), a clinical benefit rate of 28% (7/25) at 12 weeks, a progression-free survival of 2.5 months, and overall survival of 9.2 months when treated with LY3023414 (PMID: 31880826; NCT01775072). 31880826
PIK3CA G118D lung non-small cell carcinoma sensitive LY3023414 Preclinical - Cell line xenograft Actionable In a preclinical study, LY3023414 inhibited proliferation of non-small cell lung cancer cells harboring PIK3CA G118D in culture, resulted in tumor growth inhibition in cell line xenograft models (PMID: 27439478). 27439478
Unknown unknown Advanced Solid Tumor not applicable LY3023414 Phase I Actionable In a Phase I trial, LY3023414 demonstrated tolerability and inhibition of PI3K/mTOR signaling and resulted a disease control rate of 34.0% (16/47) in patients with advanced solid tumors, with one partial response and 15 patients achieving stable disease (PMID: 29636360; NCT01655225). detail... 29636360

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02443337 Phase II Necitumumab LY3023414 A Study of LY3023414 and Necitumumab in Squamous Lung Cancer Terminated
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting
NCT02407054 Phase II Enzalutamide LY3023414 A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer Completed
NCT02549989 Phase II LY3023414 Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Active, not recruiting
NCT04032080 Phase II Prexasertib LY3023414 Treatment With Oral LY3023414 To Inhibit Homologous Recombination Followed By Prexasertib (ExIST) Recruiting
NCT02784795 Phase I Cisplatin + Gemcitabine + LY3039478 Carboplatin + Gemcitabine + LY3039478 LY3023414 + LY3039478 Abemaciclib + LY3039478 LY3039478 + Taladegib LY3039478 LY3023414 A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Completed
NCT02632994 Expanded access LY3023414 LY2503029 Master Rollover Protocol for Continued Safety Assessment of Study Drug Available
NCT02079636 Phase I LY3023414 Abemaciclib Gemcitabine Pemetrexed Disodium Ramucirumab A Study of LY2835219 in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC) Completed
NCT01655225 Phase I LY3023414 + Midazolam Letrozole + LY3023414 LY3023414 A Study of LY3023414 in Participants With Advanced Cancer Active, not recruiting
NCT03213678 Phase II LY3023414 PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) Recruiting


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