Therapy Detail

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Therapy Name Abemaciclib
Synonyms
Therapy Description

Verzenio (abemaciclib) is a dual CDK4/6 inhibitor, which inhibits Rb1 protein phosphorylation and may induce cell cycle arrest and prevent growth in cancer cells (PMID: 24919854). Verzenio (abemaciclib) is FDA approved as a monotherapy and in combination with Faslodex (fulvestrant) in patients with hormone receptor-positive (ESR, PGR) and ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Abemaciclib Verzenio LY2835219 CDK4/6 Inhibitor 11 Verzenio (abemaciclib) is a dual CDK4/6 inhibitor, which inhibits Rb1 protein phosphorylation and may induce cell cycle arrest and prevent growth in cancer cells (PMID: 24919854). Verzenio (abemaciclib) is FDA approved as a monotherapy and in combination with Faslodex (fulvestrant) in patients with hormone receptor-positive (ESR, PGR) and ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive (ESR, PGR) and ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score equals to or over 20% (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CDKN2A loss chordoma sensitive Abemaciclib Preclinical - Cell culture Actionable In a preclinical study, Abemaciclib (LY2835219) inhibited growth of chordoma cell lines with CDKN2A loss and loss of p16 protein expression in culture (PMID: 26183925). 26183925
CDKN2A loss NRAS mut melanoma sensitive Abemaciclib Phase I Actionable In a Phase I trial, Abemaciclib (LY2835219) resulted in a partial response in a melanoma patient with CDKN2A loss and NRAS mutation (PMID: 27217383). detail... 27217383
KMT2A - AFF4 leukemia predicted - sensitive Abemaciclib Preclinical - Cell culture Actionable In a preclinical study, treatment with Verzenio (abemaciclib) induced apoptosis, reduced expression of Brd4 and Brd4-regulated proteins, including c-Myc, Cdk6, and Bcl-2, and resulted in an anti-tumor effect by inducing cell cycle arrest in leukemia cells harboring a KMT2A-AFF4 fusion that had developed resistance to Birabresib (OTX015) in culture (Cancer Res 2020;80(16 Suppl):Abstract nr 643.) detail...
PIK3CA H1047R oral squamous cell carcinoma decreased response Abemaciclib Preclinical - Cell culture Actionable In a preclinical study, oral squamous cell carcinoma cells expressing PIK3CA H1047R demonstrated reduced sensitivity to Verzenio (abemaciclib) treatment compared to cells expressing wild-type PIK3CA in culture (PMID: 31516747). 31516747

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04298983 Phase II Abemaciclib Abemaciclib in Combination With Androgen Deprivation Therapy for Locally Advanced Prostate Cancer (RAD 1805) 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
NCT02117648 Phase I Abemaciclib + Clarithromycin Abemaciclib A Study of LY2835219 in Participants With Cancer Completed USA 0
NCT02792725 Expanded access Abemaciclib Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Approved for marketing USA 0
NCT04751929 Phase II Abemaciclib + Atezolizumab Atezolizumab Abemaciclib Abemaciclib With or Without Atezolizumab for mCRPC Recruiting USA 0
NCT04469764 Phase II Abemaciclib + Anastrozole Abemaciclib + Letrozole Abemaciclib Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer Recruiting USA 0
NCT04305834 Phase II Abemaciclib Abemaciclib Monotherapy in Treating Older Patients With Hormone Receptor Positive Metastatic Breast Cancer Recruiting USA 0
NCT03979508 Phase II Abemaciclib Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer Recruiting USA 0
NCT03969706 Phase II Abemaciclib Abemaciclib in Patients With Oligodendroglioma Recruiting USA 0
NCT04750928 Phase Ib/II Abemaciclib Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas Recruiting USA 0
NCT04752332 Phase III Abemaciclib A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER) Recruiting USA 24
NCT03155997 Phase III Abemaciclib Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE) Active, not recruiting USA | CAN 36
NCT02688088 Phase I Abemaciclib Caffeine + Dextromethorphan + Midazolam + Warfarin A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body Completed USA 0
NCT02441946 Phase II Abemaciclib Loperamide Anastrozole A Phase 2 Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer Completed USA | CAN 8
NCT04010357 Phase II Abemaciclib Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC Recruiting USA 0
NCT03891784 Phase II Abemaciclib Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors Recruiting USA 0
NCT04523857 Phase II Abemaciclib Abemaciclib + Hydroxychloroquine ABemacicliB, HydroxYchloroquine, or the Combination to Target Minimal Residual Disease in Breast Cancer (ABBY) Recruiting USA 0
NCT02981940 Phase II Abemaciclib A Study of Abemaciclib in Recurrent Glioblastoma Recruiting USA 0
NCT04272645 Phase II Abemaciclib + Atezolizumab Abemaciclib Atezolizumab Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer Withdrawn USA 0
NCT03837821 Phase I Abemaciclib Window of Opportunity Trial of Abemaciclib for Bladder Cancer Recruiting USA 0
NCT03339843 Phase II Abemaciclib Multiorgan Metabolic Imaging Response Assessment of Abemaciclib (MiMe-A) Active, not recruiting 2
NCT04003896 Phase II Abemaciclib A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy Active, not recruiting USA 0
NCT02747004 Phase II Abemaciclib + Loperamide Abemaciclib Abemaciclib + Tamoxifen A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (Next MONARCH 1) Active, not recruiting USA 13
NCT04565054 Phase III Abemaciclib Tamoxifen Adj. Dyn. Marker-adjusted Personalized Therapy Comparing Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC (ADAPTlate) Recruiting 1
NCT04967521 Phase III Abemaciclib SARC041: Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma Recruiting USA 0
NCT04923542 Phase Ib/II Abemaciclib Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases Recruiting USA 0
NCT03356223 Phase II Abemaciclib Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6 (ABORL) Recruiting 1
NCT02308020 Phase II Abemaciclib A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain Completed USA | CAN 7
NCT03220646 Phase II Abemaciclib The Purpose of This Study is to Test Any Good and Bad Effects of a Study Drug Called Abemaciclib (LY2835219) in Patients With Recurrent Brain Tumors. Active, not recruiting USA 0
NCT02981342 Phase II Capecitabine Abemaciclib Gemcitabine Abemaciclib + LY3023414 Abemaciclib + Galunisertib A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma Completed USA 7
NCT03994796 Phase II Abemaciclib GDC-0084 Entrectinib Genetic Testing in Guiding Treatment for Patients With Brain Metastases Recruiting USA 0
NCT04040205 Phase II Abemaciclib Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Recruiting USA 0
NCT02450539 Phase II Abemaciclib Docetaxel A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer Completed USA 12
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer Recruiting USA 0
NCT03763604 Expanded access Abemaciclib Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Available CAN 13
NCT04408924 Phase II Abemaciclib Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1) Active, not recruiting USA 2
NCT02846987 Phase II Abemaciclib Study of Abemaciclib in Dedifferentiated Liposarcoma Active, not recruiting USA 0
NCT03130439 Phase II Abemaciclib Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Active, not recruiting USA 0
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 USA 1
NCT02644460 Phase I Abemaciclib Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors Recruiting USA 0
NCT04941274 Phase Ib/II Abemaciclib Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma Recruiting USA 0
NCT04552769 Phase II Abemaciclib Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer Recruiting USA 0
NCT04169074 Phase II Abemaciclib Abemaciclib + Nivolumab Modulation of the Tumor Microenvironment by Abemaciclib in Operable HPV-Negative Head and Neck Cancer (HNC) Recruiting USA 0
NCT02057133 Phase I Abemaciclib + Loperamide + Pertuzumab + Trastuzumab Abemaciclib + Fulvestrant + LY3023414 Abemaciclib + Letrozole Abemaciclib + Exemestane Abemaciclib Abemaciclib + Everolimus + Exemestane Abemaciclib + Anastrozole Abemaciclib + Tamoxifen Abemaciclib + Trastuzumab A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread Active, not recruiting USA 0
NCT04627064 Phase I Abemaciclib + Belzutifan Abemaciclib ABEMA Alone or in COMBO With MK-6482 Recruiting USA 0
NCT03310879 Phase II Abemaciclib Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6 Recruiting USA 0
NCT02152631 Phase III Erlotinib Abemaciclib A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer (JUNIPER) Active, not recruiting USA | CAN 19


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