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 35
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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: 339 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

  • 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 will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org / news as they become available while the study is ongoing.
    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

  • Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer – Dose-Finding Study

    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: 7 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: 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, spread to other places in the body or is resistant to standard treatments. 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, 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 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: 3 locations

  • 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

  • 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 the Treatment of Rb Wild-Type Refractory or Relapsed Extensive Stage Small Cell Lung Cancer

    This phase II trial studies how well abemaciclib works for the treatment of Rb wild-type extensive stage small cell lung cancer that does not respond to treatment (refractory) or has come back (relapsed). Abemaciclib may shrink lung cancer tumors in the body and stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • 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 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

  • Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

    This phase Ib trial determines if samples from a patient’s cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • 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 (recurrent) or that has spread to other parts in the body (metastatic) 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


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