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, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence, and in combination with an aromatase inhibitor as initial therapy for patients with hormone receptor-positive, 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 13 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, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence, and in combination with an aromatase inhibitor as initial therapy for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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
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
BRAF V600E melanoma predicted - sensitive Abemaciclib Preclinical - Cell line xenograft Actionable In a preclinical study, Verzenio (abemaciclib) induced apoptosis in Zelboraf (vemurafenib)-resistant melanoma cells harboring BRAF V600E in culture, and induced tumor regression in xenograft models (PMID: 25122067). 25122067
CDKN2A loss NRAS mut melanoma predicted - sensitive Abemaciclib Case Reports/Case Series Actionable In a Phase I trial, Verzenio (abemaciclib) resulted in a partial response in a melanoma patient with CDKN2A loss and NRAS mutation (PMID: 27217383). 27217383

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03155997 Phase III Abemaciclib Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 28
NCT03339843 Phase II Abemaciclib Multiorgan Metabolic Imaging Response Assessment of Abemaciclib (MiMe-A) Completed FRA | BEL 0
NCT02846987 Phase II Abemaciclib Study of Abemaciclib in Dedifferentiated Liposarcoma 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 | GBR | FRA | ESP | BEL | AUS 2
NCT05940493 Phase II Abemaciclib Abemaciclib in Newly Diagnosed Meningioma Patients Not yet recruiting USA 0
NCT04298983 Phase II Abemaciclib Abemaciclib in Combination With Androgen Deprivation Therapy for Locally Advanced Prostate Cancer (RAD 1805) Active, not recruiting USA 0
NCT06179303 Phase II Tamoxifen Exemestane Abemaciclib Fulvestrant Letrozole Anastrozole Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer Not yet recruiting USA 0
NCT03994796 Phase II Abemaciclib GDC-0084 Entrectinib Genetic Testing in Guiding Treatment for Patients With 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
NCT05413304 Phase I Abemaciclib + Temozolomide Abemaciclib Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis Recruiting USA 0
NCT04003896 Phase II Abemaciclib A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy Terminated 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
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 | AUS 1
NCT03763604 Expanded access Abemaciclib Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Available ITA | GBR | ESP | CAN | AUS 9
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
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
NCT02925234 Phase II Palbociclib Ribociclib Lenvatinib Ipilimumab + Nivolumab Trametinib Crizotinib Niraparib Selpercatinib Olaparib Erlotinib Erdafitinib Dabrafenib Dacomitinib Rucaparib Axitinib Panitumumab Pemigatinib Durvalumab Afatinib Entrectinib Tepotinib Alpelisib Atezolizumab + Bevacizumab Alectinib Regorafenib Cobimetinib + Vemurafenib Nilotinib Vismodegib Abemaciclib Sunitinib Nivolumab Cabozantinib Lorlatinib Talazoparib Dabrafenib + Trametinib Pembrolizumab Pertuzumab + Trastuzumab The Drug Rediscovery Protocol (DRUP Trial) (DRUP) Recruiting 1
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
NCT04565054 Phase III Abemaciclib Tamoxifen Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC (ADAPTlate) Recruiting DEU 0
NCT04584853 Phase III Abemaciclib PreOperative Endocrine Therapy for Individualised Care With Abemaciclib (POETIC-A) Recruiting GBR 0
NCT04040205 Phase II Abemaciclib Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Recruiting USA 0
NCT04941274 Phase Ib/II Abemaciclib Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma 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) Completed FRA 0
NCT06001762 Phase II Tamoxifen Exemestane Abemaciclib Anastrozole Letrozole TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer Recruiting USA 0
NCT04751929 Phase II Abemaciclib + Atezolizumab Atezolizumab Abemaciclib Abemaciclib With or Without Atezolizumab for mCRPC Active, not 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
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 | AUS 7
NCT03969706 Phase II Abemaciclib Abemaciclib in Patients With Oligodendroglioma Active, not 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
NCT03837821 Phase I Abemaciclib Window of Opportunity Trial of Abemaciclib for Bladder Cancer Recruiting USA 0
NCT04272645 Phase II Abemaciclib + Atezolizumab Abemaciclib Atezolizumab Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer Withdrawn 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
NCT04967521 Phase III Abemaciclib SARC041: Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma Recruiting USA 0
NCT02644460 Phase I Abemaciclib Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors Completed USA 0
NCT02117648 Phase I Abemaciclib + Clarithromycin Abemaciclib A Study of LY2835219 in Participants With Cancer Completed USA 0
NCT03891784 Phase II Abemaciclib Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors Recruiting USA 0
NCT04408924 Phase II Abemaciclib Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1) Completed USA | FRA | ESP 0
NCT04523857 Phase II Abemaciclib Abemaciclib + Hydroxychloroquine ABemacicliB, HydroxYchloroquine, or the Combination to Target Minimal Residual Disease in Breast Cancer (ABBY) Recruiting USA 0
NCT03220646 Phase II Abemaciclib Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors Active, not 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
NCT02981940 Phase II Abemaciclib A Study of Abemaciclib in Recurrent Glioblastoma Active, not recruiting 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
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) Active, not recruiting GBR 0
NCT04923542 Phase Ib/II Abemaciclib Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases Recruiting USA 0
NCT04627064 Phase I Abemaciclib + Belzutifan Abemaciclib ABEMA Alone or in COMBO With MK-6482 Active, not 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
NCT04552769 Phase II Abemaciclib Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer Active, not recruiting USA 0
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
NCT04752332 Phase III Abemaciclib A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 11
NCT04010357 Phase II Abemaciclib Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC Recruiting USA 0
NCT03130439 Phase II Abemaciclib Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Terminated USA 0
NCT06169371 FDA approved Abemaciclib Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI) (BRE-09) Recruiting 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 | ITA | ESP | DEU | CAN | BEL | AUT 3
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) Terminated AUS 0
NCT04469764 Phase II Abemaciclib + Anastrozole Abemaciclib + Letrozole Abemaciclib Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer Recruiting USA 0
NCT06025747 Phase I Abemaciclib Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma Not yet recruiting USA 0
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


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