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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