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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