Clinical Trials Using Abemaciclib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Abemaciclib. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 26
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  • Genetic Testing in Guiding Treatment for Patients with Brain Metastases

    This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.
    Location: 254 locations

  • Abemaciclib, DNA-PK / TOR Kinase Inhibitor CC-115, or Neratinib in Treating Patients with Brain Tumors after Biomarker Screening

    This randomized phase II trial studies how well abemaciclib, DNA-PK / TOR kinase inhibitor CC-115, or neratinib works in treating patients with brain tumors after biomarker screening. Drugs such as abemaciclib, DNA-PK / TOR kinase inhibitor CC-115, or neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Screening tumor samples for biomarkers may help doctors to determine if certain treatments work better on patients with certain biomarkers. Giving abemaciclib, DNA-PK / TOR kinase inhibitor CC-115, or neratinib may work better in treating patients with brain tumors.
    Location: 12 locations

  • Myeloma-Developing Regimens Using Genomics (MyDRUG)

    The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).
    Location: 10 locations

  • Abemaciclib in Treating Patients with Recurrent Brain Tumors

    This phase II trial studies how well abemaciclib works in treating patients with brain tumors that have come back. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 9 locations

  • 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

    The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).
    Location: 9 locations

  • Abemaciclib in Treating Patients with Recurrent Glioblastoma

    This phase II trial studies how well abemaciclib works in treating patients with glioblastoma that has come back after a period of improvement. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 8 locations

  • Fulvestrant and Abemaciclib in Treating Patients with Hormone Receptor Positive Recurrent or Refractory Endometrial Adenocarcinoma

    This phase II trial studies how well fulvestrant and abemaciclib work in treating patients with hormone receptor positive endometrial adenocarcinoma that has come back or does not respond to treatment. Fulvestrant and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 locations

  • A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

    This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4 / 6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and / or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
    Location: 6 locations

  • A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced / Metastatic Cancer

    The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1 / 2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.
    Location: 8 locations

  • This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer.

    For each dose finding cohorts (A, B, C and D): The primary objective of each dose finding cohort is to determine the maximum tolerated dose (MTD) / recommended phase II dose (RP2D) of xentuzumab in combination with abemaciclib with or without hormonal therapy (letrozole, anastrozole, fulvestrant). Dose limiting toxicities (DLT) will be assessed during the first treatment cycle to assess the MTD / RP2D. In case that no MTD is reached a RP2D dose will be determined taking into account safety data and other available information. This will be agreed with the Steering Committee. For each expansion cohorts (E, F, D1 and D2): The objectives of the expansion cohorts are to assess the anti-tumour activity of xentuzumab in combination with abemaciclib in patients with non-small cell lung cancer (cohort E). Tentatively a cohort F may be opened to assess the anti-tumour activity of the triplet combination xentuzumab / abemaciclib and fulvestrant in a single-arm expansion group of patients with locally advanced / metastatic hormone receptor positive (HR+) breast cancer who have progressed following prior aromatase inhibitor therapy and prior CDK4 / 6 inhibitor treatment. Cohort F will only be opened if indicated by emerging data from ongoing clinical trials. The primary objective of cohorts D1 and D2 is to assess the anti-tumour activity of the triplet combination xentuzumab, abemaciclib and fulvestrant in patients with locally advanced / metastatic HR+ breast cancer who have progressed on prior endocrine therapy. Cohort D1 will assess the anti-tumour activity for subjects with visceral metastasis and Cohort D2 for subjects with non-visceral metastasis.
    Location: 4 locations

  • Abemaciclib and Radiation Therapy in Treating Younger Patients with Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Recurrent or Refractory Solid Tumors, or Malignant Brain Tumors

    This phase I trial studies the side effects and best dose of abemaciclib when given together with radiation therapy in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma (a type of central nervous system tumor that forms from glial [supportive] tissue of the brain and spinal cord), or solid tumors that have come back (recurrent) or does not respond to treatment (refractory), or malignant brain tumors. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy may be a better treatment in patients with diffuse intrinsic pontine glioma, solid tumors, or malignant brain tumors.
    Location: 3 locations

  • A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

    This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide) for breast cancer that has spread to other parts of the body.
    Location: 4 locations

  • A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

    This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
    Location: 3 locations

  • A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

    The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
    Location: 2 locations

  • Abemaciclib and Pembrolizumab in Treating Patients with Locally Advanced Unresectable or Metastatic Gastroesophageal, Gastric, or Esophageal Cancer

    This phase II trial studies how well abemaciclib and pembrolizumab work in treating patients with gastroesophageal, gastric, or esophageal cancer that has spread from its original site of growth to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable), or has spread to other places in the body (metastatic). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving abemaciclib and pembrolizumab may work better in treating patients with gastroesophageal, gastric, or esophageal cancer compared to pembrolizumab alone.
    Location: University of Wisconsin Hospital and Clinics, Madison, Wisconsin

  • Abemaciclib in Treating Patients with Recurrent Oligodendroglioma

    This phase II trial studies how well abemaciclib works in treating patients with oligodendroglioma that has come back after previous treatment. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • Abemaciclib in Treating Patients with Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors

    This phase II trial studies how well abemaciclib works in treating patients with digestive system neuroendocrine tumors that have spread to other places in the body, do not respond to treatment, and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Abemaciclib and Nivolumab for the Treatment of Inoperable Liver Cancer

    This phase II trial studies how well abemaciclib and nivolumab work in treating liver cancer that cannot be treated by surgery (inoperable). Abemaciclib is a cancer therapy that may slow cancer growth by preventing cells from dividing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer by “removing the brakes” of the immune system, and may interfere with the ability of tumor cells to grow and spread. Giving abemaciclib and nivolumab may work better in treating liver cancer compared to nivolumab alone.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • Abemaciclib and Nivolumab in Treating Patients with Recurrent or Metastatic Head and Neck Squamous Cell Cancer that Progressed or Recurred after Platinum-Based Chemotherapy

    This phase I / II trial studies the side effects and best dose of abemaciclib and how well it works when given together with nivolumab in treating patients with head and neck squamous cell cancer that has come back or that has spread to other parts in the body and for which no treatment is currently available after platinum-based chemotherapy. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving abemaciclib and nivolumab may work better in treating patients with recurrent or metastatic head and neck cancer.
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • Fulvestrant and Abemaciclib in Treating Patients with Stage III- IV Low Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    This pilot phase II trial studies how well fulvestrant and abemaciclib work in treating patients with stage III-IV low grade serous ovarian, primary peritoneal, or fallopian tube cancer. Fulvestrant and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 5 locations

  • Abemaciclib in Treating Patients with Rb Positive Triple-Negative Breast Cancer That is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed by Surgery

    This phase II trial studies how well abemaciclib works in treating patients with retinoblastoma (Rb) positive triple-negative breast cancer that has come back, has spread to other places in the body, or cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Dana-Farber Cancer Institute, Boston, Massachusetts

  • Abemaciclib in Treating Patients with Recurrent, Locally Advanced, or Metastatic Dedifferentiated Liposarcoma That Cannot Be Removed by Surgery

    This phase II trial studies how well abemaciclib works in treating patients with dedifferentiated liposarcoma that has come back or has spread from where it started to other places in the body and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors

    The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Abemaciclib and Letrozole in Treating Patients with Endometrial Cancer

    This early phase I trial studies how well abemaciclib and letrozole work in treating patients with endometrial cancer and determines whether there are changes in patients' cancer cell biomarkers (a genetic feature or specific protein) for cell growth before and after treatment. Antihormone therapy with aromatase inhibitors, such as letrozole, may lessen the amount of estrogen made by the body. Abemaciclib blocks the activities of a class of proteins called cyclin-dependent kinase, which are involved in cell duplication. Giving letrozole and abemaciclib together may slow down cancer cell growth in patients with endometrial cancer.
    Location: 2 locations

  • Abemaciclib in Treating Patients with Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer

    This phase II trial studies how well abemaciclib works in treating patients with triple negative breast cancer that can be removed by surgery and does not respond to treatment with chemotherapy. Abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: Mayo Clinic, Rochester, Minnesota


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