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 40
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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: 344 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: 13 locations

  • Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer

    This phase I / II trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative stage IV breast cancer. Some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer.
    Location: 10 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: 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: 10 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: 10 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. Prednisolone may be used instead of prednisone per local regulation.
    Location: 11 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 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

  • 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: 7 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

  • 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.

    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, D1, D2 and F): 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). Cohort F will 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+) HR2- breast cancer who have progressed following Prior therapy with an aromatase inhibitor and different CDK4 / 6 inhibitor (excluding abemaciclib). 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

  • 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

  • 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: 6 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 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

  • 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

  • Abemaciclib for the Treatment of Unresectable or Metastatic Anaplastic / Undifferentiated Thyroid Cancer

    This phase II trial studies the effect of abemaciclib in treating patients with a rare, aggressive type of thyroid cancer in which the tumor cells look very different from normal thyroid cells (anaplastic / undifferentiated) and cannot be removed by surgery (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.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • ERK1 / 2 Inhibitor LY3214996 and Abemaciclib for the Treatment of Advanced, Metastatic, or Unresectable Cancer Harboring Mutations in BRAF, RAF1, MEK1 / 2, ERK1 / 2, and NF1

    This phase II trial studies how well ERK1 / 2 inhibitor LY3214996 and abemaciclib work in treating patients with cancer that has spread to other places in the body (advanced / metastatic) or cannot be removed by surgery (unresectable) and harbor the mutations in BRAF, RAF1, MEK1 / 2, ERK1 / 2, and NF1. ERK1 / 2 inhibitor LY3214996 and abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: Indiana University / Melvin and Bren Simon Cancer Center, Indianapolis, Indiana

  • Abemaciclib Monotherapy in Treating Older Patients with Hormone Receptor Positive Metastatic Breast Cancer

    This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • Abemaciclib and Androgen Deprivation Therapy for the Treatment of Localized High-Risk or Locally Advanced Prostate Cancer

    This phase II trial studies the effect of abemaciclib and androgen deprivation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) and is high-risk, or has spread to nearby tissue or lymph nodes (locally advanced). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Since prostate cancer is driven prominently by high testosterone levels, drugs used in androgen deprivation therapy, such as goserelin acetate and leuprolide acetate, act to reduce the levels of testosterone and thus slow the growth of prostate cancer. Abemaciclib may work with androgen deprivation therapy to control growth and spread of prostate cancer so as to make the patient’s tumor better receptive to radiation therapy and improve outcomes to radiation therapy.
    Location: University of Alabama at Birmingham Cancer Center, Birmingham, Alabama

  • Aromatase Inhibitor Therapy with or without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer with an ERS1 Activating Mutation, the INTERACT Study

    This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and / or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has spread to other places in the body (metastatic) and has an ERS1 activating mutation. Letrozole, anastrozole, ribociclib, palbociclib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known if giving letrozole, anastrozole, or fulvestrant with ribociclib, palbociclib, and / or abemaciclib will work better in treating patients with breast cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Abemaciclib and Bevacizumab for the Treatment of Recurrent Glioblastomas with Loss of CDKN2A / B or Gain of CDK4 / 6

    This early phase I trial studies the side effects of abemaciclib when giving together with bevacizumab in treating patients with glioblastomas that have come back after a period of improvement (recurrent) with loss of CDKN2A / B or gain of CDK4 / 6. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving abemaciclib and bevacizumab may work better in treating patients with recurrent glioblastomas compared to bevacizumab alone.
    Location: UT Southwestern / Simmons Cancer Center-Dallas, Dallas, Texas

  • 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


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