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 9 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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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
Unknown unknown Her2-receptor positive breast cancer not applicable Abemaciclib Preclinical - Pdx & cell culture Actionable In a preclinical study, an ERBB2 (HER2)-receptor positive breast cancer cell line xenograft model treated with Abemaciclib (LY2835219) demonstrated delayed tumor growth and in culture, resulted in some decreased cell viability (PMID: 26977878). 26977878
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
Unknown unknown head and neck squamous cell carcinoma not applicable Abemaciclib Preclinical Actionable In a preclinical study, Abemaciclib (LY2835219) reduced RB and AKT activation, and inhibited cell proliferation and colony formation in head and neck squamous cell carcinoma (HNSCC) cell lines in culture, and inhibited tumor growth in HNSCC xenograft models (PMID: 26909611). 26909611
Unknown unknown glioblastoma multiforme not applicable Abemaciclib Phase I Actionable In a Phase I trial, three patients with glioblastoma demonstrated stable disease when treated with Abemaciclib (LY2835219) (PMID: 27217383). 27217383
Unknown unknown ovarian cancer not applicable Abemaciclib Preclinical Actionable In a preclinical study, LY2835219 treatment reduced tumor growth and increased survival in ovarian cancer xenograft models (American Association for Cancer Research; 2013 Apr 6-10; Abstract LB-122). detail...
Unknown unknown ovarian cancer not applicable Abemaciclib Phase I Actionable In a Phase I trial, two ovarian cancer patients treated with Abemaciclib (LY2835219) demonstrated stable disease while another ovarian cancer patient achieved a partial response (PMID: 27217383). 27217383
Unknown unknown ovarian cancer not applicable Abemaciclib Preclinical Actionable In a preclinical study, LY2835219 alone, and in combination with Gemzar (gemcitabine), reduced tumor growth in xenograft models of solid tumors including ovarian cancers (PMID: 24919854). 24919854
Unknown unknown melanoma not applicable Abemaciclib Phase I Actionable In a Phase I trial, treatment with Abemaciclib (LY2835219) in melanoma patients resulted in a disease control rate of 27% (7/26), a partial response in one patient and six patients with stable disease (PMID: 27217383). 27217383
Unknown unknown lung non-small cell carcinoma not applicable Abemaciclib Phase I Actionable In a Phase I trial, treatment with Abemaciclib (LY2835219) in patients with non-small cell lung carcinoma resulted in a disease control rate of 49% (33/68), including 46% (31/68) with stable disease and 3% (2/68) with a partial response, and a 6 month PFS of 26% (PMID: 27217383, PMID: 24795392). 24795392 27217383
Unknown unknown colorectal cancer not applicable Abemaciclib Phase I Actionable In a Phase I trial, treatment with Abemaciclib (LY2835219) in colorectal cancer patients resulted in 2 patients (13%; 2/15) with stable disease (PMID: 27217383). 27217383

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02846987 Phase II Abemaciclib Study of Abemaciclib in Dedifferentiated Liposarcoma Active, not recruiting
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
NCT02152631 Phase III Erlotinib Abemaciclib A Study of LY2835219 in Participants With Previously Treated Lung Cancer Active, not recruiting
NCT03994796 Phase II Abemaciclib GDC-0084 Entrectinib Genetic Testing in Guiding Treatment for Patients With Brain Metastases Recruiting
NCT04040205 Phase II Abemaciclib Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration Recruiting
NCT03837821 Phase I Abemaciclib Window of Opportunity Trial of Abemaciclib for Bladder Cancer Recruiting
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 in Combination With Hormone Therapies for Breast Cancer That Has Spread Active, not recruiting
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 Active, not recruiting
NCT04272645 Phase II Abemaciclib + Atezolizumab Abemaciclib Atezolizumab Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer Not yet recruiting
NCT04305834 Phase II Abemaciclib Abemaciclib Monotherapy in Treating Older Patients With Hormone Receptor Positive Metastatic Breast Cancer Recruiting
NCT02450539 Phase II Abemaciclib Docetaxel A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer Active, not recruiting
NCT02792725 Expanded access Abemaciclib Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Approved for marketing
NCT02644460 Phase I Abemaciclib Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors Recruiting
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
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
NCT03155997 Phase III Abemaciclib Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE) Active, not recruiting
NCT03891784 Phase II Abemaciclib Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors Recruiting
NCT03310879 Phase II Abemaciclib A Phase II Study of the CDK4/6 Inhibitor Abemaciclib in Patients With Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6 Recruiting
NCT03130439 Phase II Abemaciclib Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Recruiting
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
NCT02747004 Phase II Abemaciclib + Loperamide Abemaciclib Abemaciclib + Tamoxifen A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1) Active, not recruiting
NCT04010357 Phase II Abemaciclib Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC Recruiting
NCT02981940 Phase II Abemaciclib A Study of Abemaciclib in Recurrent Glioblastoma Active, not recruiting
NCT04003896 Phase II Abemaciclib A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy Not yet recruiting
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. Recruiting
NCT04408924 Phase II Abemaciclib Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1) Not yet recruiting
NCT03763604 Expanded access Abemaciclib Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer Available
NCT02117648 Phase I Abemaciclib + Clarithromycin Abemaciclib A Study of LY2835219 in Participants With Cancer Completed
NCT03969706 Phase II Abemaciclib Abemaciclib in Patients With Oligodendroglioma Active, not recruiting
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
NCT03979508 Phase II Abemaciclib Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer Recruiting


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