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 47
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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: 357 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 25% 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 25% 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: 16 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

  • 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). ********************************************************************************************* ********************************************************************************* Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org / news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ********************************************************************************************* *********************************************************************************
    Location: 11 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 (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 9 locations

  • A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

    The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
    Location: 12 locations

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

    This phase II trial studies how well fulvestrant and abemaciclib work in treating patients with hormone receptor positive endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Estrogen can cause the growth of endometrial cancer cells. Fulvestrant blocks the use of estrogen by estrogen receptor positive tumor cells. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant and abemaciclib may help treat patients with endometrial cancer.
    Location: 7 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 (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 8 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

  • Abemaciclib and Letrozole to Treat Endometrial Cancer

    This is a phase II single arm trial to evaluate the objective response rate of abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator / patient request for withdrawal.
    Location: 5 locations

  • Abemaciclib and Letrozole in Treating Patients with Recurrent, Metastatic, or Resistant Endometrial Cancer

    This phase II trial studies how well abemaciclib and letrozole work in treating patients with endometrial cancer that has come back (recurrent), spread to other places in the body (metastatic) or remains despite treatment (resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Letrozole is a hormonal therapy that works by lowering the production of estrogen in the body. Estrogen may help to stimulate cancer cells to grow, so lowering the levels of estrogen in the body may work to slow cancer cell growth. Giving abemaciclib together with letrozole may work better in treating patients with endometrial cancer.
    Location: 4 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.

    "This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: - Xentuzumab in combination with abemaciclib - Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer. Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib. For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."
    Location: 4 locations

  • Stereotactic Radiosurgery with Abemaciclib, Ribociclib, or Palbociclib in Treating Patients with Hormone Receptor Positive Breast Cancer with Brain Metastases

    This phase I trial studies the side effects of stereotactic radiosurgery with abemaciclib, ribociclib, or palbociclib in treating patients with hormone receptor positive breast cancer that has spread to the brain (brain metasteses). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Abemaciclib, ribociclib, and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib, ribociclib, or palbociclib concurrently with stereotactic radiosurgery may reduce the side effects and / or increase the response to each of the therapies.
    Location: 3 locations

  • T-DM1 with or without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer

    This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic). T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and abemaciclib may work better in treating patients with breast cancer compared to T-DM1 alone.
    Location: 9 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 (resectable) 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: 3 locations

  • Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer

    A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)
    Location: 3 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

  • Abemaciclib with or without MK-6482 for the Treatment of Advanced Kidney Cancer

    This phase I / IB trial is to find out the best dose of abemaciclib and its effect in combination with MK-6482 for the treatment of kidney cancer that has spread to other places in the body (advanced). Abemaciclib is in a class of drugs known as CDK4 & 6 inhibitors. These proteins control how fast cells grow and divide and are found on both normal and tumor cells. They become overactive in tumor cells causing cells to grow and divide uncontrollably. Abemaciclib blocks these proteins just as the cells start to grow and divide and in other cancers has been shown to slow down tumor cell growth and division, causing tumor cells to become inactive or even die. MK-6482 is a small-molecule inhibitor that targets a protein called HIF-2a, which promotes the growth of new vessels that fuel kidney cancer. Giving abemaciclib and MK-6482 may be safe and effective in slowing down the growth of advanced kidney cancer.
    Location: 2 locations

  • Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+ / HER2- Breast Cancer With an ESR1 Mutation

    This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+ / HER2- breast cancer who have disease progression on first and / or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
    Location: 3 locations

  • 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 for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration

    This is a single-arm, phase II study that will enroll a total of 45 subjects. All subjects will have a confirmed diagnosis of metastatic or unresectable soft tissue sarcoma or bone sarcoma. All subjects must have intact Rb, identified at the time of screening, by immunohistochemistry testing of submitted tumor specimen. Subjects will receive Abemaciclib 200 mg twice daily until progression or discontinuation criteria are met.
    Location: 2 locations

  • Abemaciclib in Treating Patients with Advanced Solid Tumors with CCND1 / 2 / 3 and CDK4 / 6 Genetic Alterations

    This phase II trial studies how well abemaciclib works in treating patients with solid tumors with CCND1 / 2 / 3 and CDK4 / 6 genetic alterations that have spread to other places. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

    This is a Phase Ib / II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The current cohort (Cohort 1) will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor (ER)-positive breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4 / 6 inhibitor (CDK4 / 6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Testing the Addition of Abemaciclib to Olaparib for Women with Recurrent Ovarian Cancer

    This phase I / Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.
    Location: University of Virginia Cancer Center, Charlottesville, Virginia

  • LY3214996 and Cetuximab Alone or in Combination with Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer

    This phase Ib / II trial investigates the side effects and best dose of LY3214996 when given together with cetuximab alone or in combination with abemaciclib and to see how well they work in treating patients with colorectal cancer that cannot be removed by surgery (unresectable) and / or has spread to other places in the body (metastatic). Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. LY3214996 and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LY3214996 and cetuximab alone or in combination with abemaciclib may help treat patients with colorectal cancer.
    Location: M D Anderson Cancer Center, Houston, Texas


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