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 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
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
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
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
NCT02644460 Phase I Abemaciclib Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors 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
NCT03130439 Phase II Abemaciclib Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Active, not recruiting USA 0
NCT04584853 Phase III Abemaciclib PreOperative Endocrine Therapy for Individualised Care With Abemaciclib (POETIC-A) Recruiting 1
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
NCT03339843 Phase II Abemaciclib Multiorgan Metabolic Imaging Response Assessment of Abemaciclib (MiMe-A) Active, not recruiting FRA | BEL 0
NCT04923542 Phase Ib/II Abemaciclib Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases 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 | ESP 0
NCT04752332 Phase III Abemaciclib A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER) Active, not recruiting USA | ITA | FRA | ESP | DEU | BEL | AUT 17
NCT04750928 Phase Ib/II Abemaciclib Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas Recruiting USA 0
NCT04010357 Phase II Abemaciclib Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC Recruiting USA 0
NCT03654833 Phase II Bemcentinib + Pembrolizumab Rucaparib Abemaciclib Atezolizumab + Bevacizumab Dostarlimab-gxly + Niraparib Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma (MiST) Recruiting 1
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf 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 (TAPUR) Recruiting USA 0
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
NCT03220646 Phase II Abemaciclib Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors Active, not 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 FRA 0
NCT04305834 Phase II Abemaciclib Abemaciclib Monotherapy in Treating Older Patients With Hormone Receptor Positive Metastatic Breast Cancer Recruiting USA 0
NCT02523014 Phase II Abemaciclib GSK2256098 Vismodegib Capivasertib Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas Recruiting USA 0
NCT04040205 Phase II Abemaciclib Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Recruiting USA 0
NCT02981940 Phase II Abemaciclib A Study of Abemaciclib in Recurrent Glioblastoma Recruiting USA 0
NCT03763604 Expanded access Abemaciclib Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Available ITA | ESP | CAN 11
NCT02846987 Phase II Abemaciclib Study of Abemaciclib in Dedifferentiated Liposarcoma Active, not recruiting USA 0
NCT04408924 Phase II Abemaciclib Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1) Active, not recruiting USA | FRA | ESP 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
NCT04272645 Phase II Abemaciclib + Atezolizumab Abemaciclib Atezolizumab Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer Withdrawn USA 0
NCT05413304 Phase I Abemaciclib + Temozolomide Abemaciclib Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis Not yet 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
NCT02152631 Phase III Erlotinib Abemaciclib A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer (JUNIPER) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | AUT 14
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 DEU 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 | ITA | FRA | ESP | DEU | BEL | AUT 7
NCT04003896 Phase II Abemaciclib A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy 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
NCT04751929 Phase II Abemaciclib + Atezolizumab Atezolizumab Abemaciclib Abemaciclib With or Without Atezolizumab for mCRPC 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
NCT04627064 Phase I Abemaciclib + Belzutifan Abemaciclib ABEMA Alone or in COMBO With MK-6482 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 | FRA | ESP | BEL 4
NCT03837821 Phase I Abemaciclib Window of Opportunity Trial of Abemaciclib for Bladder Cancer Recruiting USA 0
NCT04469764 Phase II Abemaciclib + Anastrozole Abemaciclib + Letrozole Abemaciclib Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer Recruiting USA 0
NCT04298983 Phase II Abemaciclib Abemaciclib in Combination With Androgen Deprivation Therapy for Locally Advanced Prostate Cancer (RAD 1805) Recruiting USA 0
NCT03155997 Phase III Abemaciclib Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 30
NCT03891784 Phase II Abemaciclib Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors Recruiting USA 0
NCT04967521 Phase III Abemaciclib SARC041: Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma Recruiting USA 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
NCT03994796 Phase II Abemaciclib GDC-0084 Entrectinib Genetic Testing in Guiding Treatment for Patients With Brain Metastases 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
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 | ITA | FRA | ESP | CAN | BEL | AUT 2
NCT02450539 Phase II Abemaciclib Docetaxel A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer Completed USA | ITA | FRA | ESP | DEU 8
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 | ITA | ESP | DEU | CAN | BEL | AUT 3


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