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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). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Abemaciclib | Verzenio | LY2835219 | CDK4/6 Inhibitor 14 | 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). |
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 |
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 |
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 del | high grade glioma | sensitive | Abemaciclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Verzenio (abemaciclib) inhibited viability and G1/S transition in glioma cell lines harboring IDH1 R132H and deletion of CDKN2A in culture and inhibited tumor growth and improved survival in cell line xenograft models (PMID: 38718141). | 38718141 |
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04584853 | Phase III | Abemaciclib | PreOperative Endocrine Therapy for Individualised Care With Abemaciclib (POETIC-A) | Recruiting | GBR | 0 |
NCT04408924 | Phase II | Abemaciclib | Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1) | Completed | USA | FRA | ESP | 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 |
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 |
NCT04469764 | Phase II | Abemaciclib + Anastrozole Abemaciclib + Letrozole Abemaciclib | Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer | Recruiting | USA | 0 |
NCT04941274 | Phase Ib/II | Abemaciclib | Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma | Recruiting | USA | 0 |
NCT04040205 | Phase II | Abemaciclib | Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration | Recruiting | USA | 0 |
NCT06678269 | Phase I | Abemaciclib | A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer | 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) | Active, not recruiting | GBR | 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 | Suspended | USA | 0 |
NCT02846987 | Phase II | Abemaciclib | Study of Abemaciclib in Dedifferentiated Liposarcoma | Active, not recruiting | USA | 0 |
NCT04752332 | Phase III | Abemaciclib | A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER) | Terminated | USA | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CHE | BRA | BEL | AUT | AUS | ARG | 5 |
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 |
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 | ISR | FRA | ESP | CAN | BEL | AUT | AUS | 0 |
NCT03979508 | Phase II | Abemaciclib | Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer | 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 | ISR | GBR | FRA | ESP | BEL | AUS | 1 |
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 |
NCT04305834 | Phase II | Abemaciclib | Abemaciclib Monotherapy in Treating Older Patients With Hormone Receptor Positive Metastatic Breast Cancer | Recruiting | USA | 0 |
NCT02644460 | Phase I | Abemaciclib | Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors | Completed | USA | 0 |
NCT06025747 | Phase I | Abemaciclib | Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma | Recruiting | USA | 0 |
NCT04272645 | Phase II | Abemaciclib + Atezolizumab Abemaciclib Atezolizumab | Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer | Withdrawn | USA | 0 |
NCT04967521 | Phase III | Abemaciclib | SARC041: Study of Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma | 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 |
NCT05413304 | Phase I | Abemaciclib + Temozolomide Abemaciclib | Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis | 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 |
NCT04003896 | Phase II | Abemaciclib | A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy | Terminated | USA | 0 |
NCT03837821 | Phase I | Abemaciclib | Window of Opportunity Trial of Abemaciclib for Bladder Cancer | 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 |
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 | TUR | ITA | FRA | ESP | DEU | CZE | BRA | BEL | AUT | ARG | 3 |
NCT06630325 | Phase II | Fulvestrant Olaparib + Pegylated liposomal doxorubicin Abemaciclib + Letrozole Abemaciclib Olaparib Olaparib + Temozolomide Abemaciclib + Tamoxifen Abemaciclib + Gemcitabine Gefitinib Abemaciclib + Pemetrexed Disodium Abemaciclib + Exemestane Osimertinib Carboplatin + Gefitinib + Pemetrexed Disodium Carboplatin + Olaparib + Paclitaxel | A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced, Recurrent Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer | Not yet recruiting | USA | 0 |
NCT03220646 | Phase II | Abemaciclib | Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors | Active, not recruiting | USA | 0 |
NCT03891784 | Phase II | Abemaciclib | Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors | Active, not recruiting | USA | 0 |
NCT04923542 | Phase Ib/II | Abemaciclib | Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases | Recruiting | USA | 0 |
NCT03969706 | Phase II | Abemaciclib | Abemaciclib in Patients With Oligodendroglioma | Active, not 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) | Terminated | AUS | 0 |
NCT02450539 | Phase II | Abemaciclib Docetaxel | A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer | Completed | USA | ROU | POL | ITA | HUN | FRA | ESP | DEU | AUS | 4 |
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 |
NCT06380751 | Phase III | Ribociclib Fulvestrant Camizestrant + Saruparib Anastrozole Camizestrant + Ribociclib Letrozole Camizestrant + Palbociclib Abemaciclib + Camizestrant Exemestane Abemaciclib Palbociclib | Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (EvoPAR-BR01) | Recruiting | USA | TUR | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | AUT | AUS | ARG | 11 |
NCT04750928 | Phase Ib/II | Abemaciclib | Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas | 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 |
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 | NLD | ITA | ESP | DEU | CAN | BEL | AUT | 2 |
NCT05159245 | Phase II | Vemurafenib Tepotinib Vismodegib Apalutamide Alectinib Regorafenib Entrectinib Pertuzumab + Trastuzumab Pemigatinib Atezolizumab Cobimetinib Dabrafenib + Trametinib Dabrafenib Trametinib Abemaciclib | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs (FINPROVE) | Recruiting | FIN | 0 |
NCT04552769 | Phase II | Abemaciclib | Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer | 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 |
NCT02981940 | Phase II | Abemaciclib | A Study of Abemaciclib in Recurrent Glioblastoma | Active, not recruiting | USA | 0 |
NCT04627064 | Phase I | Abemaciclib + Belzutifan Abemaciclib | ABEMA Alone or in COMBO With MK-6482 | Active, not recruiting | USA | 0 |
NCT06044623 | Phase III | Exemestane Abemaciclib Palbociclib Ribociclib Letrozole Anastrozole Fulvestrant | Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients (IMPORTANT) | Recruiting | SWE | NOR | ITA | GRC | FIN | 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 | |
NCT03763604 | Expanded access | Abemaciclib | Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer | Available | ITA | GBR | ESP | CHE | CAN | AUS | 8 |
NCT05940493 | Phase II | Abemaciclib | Abemaciclib in Newly Diagnosed Meningioma Patients | Not yet 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 | TUR | ROU | POL | ITA | ISR | GRC | FRA | ESP | DEU | CAN | BRA | AUT | ARG | 7 |
NCT02117648 | Phase I | Abemaciclib + Clarithromycin Abemaciclib | A Study of LY2835219 in Participants With Cancer | Completed | USA | 0 |
NCT03130439 | Phase II | Abemaciclib | Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer | Terminated | USA | 0 |
NCT03339843 | Phase II | Abemaciclib | Multiorgan Metabolic Imaging Response Assessment of Abemaciclib (MiMe-A) | Completed | FRA | BEL | 0 |
NCT04010357 | Phase II | Abemaciclib | Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC | 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 | TUR | SWE | ROU | POL | NZL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 14 |
NCT06169371 | FDA approved | Abemaciclib | Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI) (BRE-09) | Recruiting | USA | 0 |
NCT04751929 | Phase II | Abemaciclib + Atezolizumab Atezolizumab Abemaciclib | Abemaciclib With or Without Atezolizumab for mCRPC | Active, not recruiting | USA | 0 |
NCT06001762 | Phase II | Tamoxifen Exemestane Abemaciclib Anastrozole Letrozole | TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage 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 | ESP | 0 |