Clinical Trials Using Enzalutamide

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Clinical trials are research studies that involve people. The clinical trials on this list are studying Enzalutamide. 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 48
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  • Enzalutamide in Treating Patients with Androgen Receptor Positive Locally Advanced or Metastatic Salivary Cancers That Cannot Be Removed by Surgery

    This phase II trial studies how well enzalutamide works in treating patients with androgen receptor positive salivary cancers that have spread from where it started to nearby tissue or lymph nodes or have spread to other places in the body and cannot be removed by surgery. Proteins called androgen receptors bind to androgens (hormones) and may cause tumor cells to grow. Enzalutamide may stop the growth of tumor cells by binding to and blocking androgen receptor proteins.
    Location: 278 locations

  • Testosterone Therapy or Enzalutamide in Treating Patients with Asymptomatic Castration Resistant Metastatic Prostate Cancer

    This randomized phase II trial compares testosterone therapy with the current standard treatment, enzalutamide, to see how well they work in treating patients with prostate cancer that is not causing signs or symptoms, has not responded to hormone therapy, and has spread to other parts of the body. Testosterone replacement therapy may help stop tumor cell growth and shrink tumors. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may fight prostate cancer by blocking the cancer cells from using androgen. It is not yet known whether testosterone therapy is more effective than enzalutamide in treating patients with prostate cancer that has not responded to hormone therapy.
    Location: 16 locations

  • Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

    The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
    Location: 12 locations

  • A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen

    This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.
    Location: 13 locations

  • Enzalutamide in Treating Patients with Stage I-III Androgen Receptor Positive Triple-Negative Breast Cancer

    This phase II trial studies how well enzalutamide works in treating patients with stage I-III androgen receptor positive triple-negative breast cancer. Androgen can cause the growth of breast cancer cells. Antihormone therapy, such as enzalutamide may lessen the amount of androgen made by the body.
    Location: 12 locations

  • A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance

    The primary purpose of this study is to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
    Location: 8 locations

  • Study of Pembrolizumab (MK-3475) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)(MK-3475-199 / KEYNOTE-199)

    This is a study of pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer (mCRPC). Participants will be enrolled into one of five cohorts: Cohort 1 (participants with programmed cell death ligand 1 [PD-L1]-positive, measurable disease), Cohort 2 (participants with PD-L1 negative, measurable disease), Cohort 3 (participants with bone-metastases and non-measurable disease) post-chemotherapy, Cohort 4 (participants with Response Evaluation Criteria in Solid Tumors version 1.1- [RECIST 1.1]-measureable disease) and Cohort 5 (participants with bone metastases only or bone-predominant disease) pre-chemotherapy.
    Location: 7 locations

  • Salvage Radiation Therapy with or without Enzalutamide in Treating Patients with High-Risk PSA-Recurrent Prostate Cancer after Radical Prostatectomy

    This randomized phase II trial studies how well salvage radiation therapy with or without enzalutamide works in treating patients with prostate cancer with high-risk prostate cancer with a rising prostate-specific antigen (PSA) after surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Enzalutamide may stop the growth of prostate cancer by blocking an important protein that keeps prostate cancer cells alive and may make prostate cells more resistant to radiation therapy. It is not yet known whether salvage radiation therapy is more effective with or without enzalutamide in treating prostate cancer.
    Location: 7 locations

  • Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

    The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.
    Location: 7 locations

  • Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients with Stage III-IV or Recurrent Endometrioid Endometrial Cancer

    This phase II trial studies how well enzalutamide, carboplatin, and paclitaxel work in treating patients with endometrioid endometrial cancer that is stage III-IV or has come back. Androgens can cause the growth of endometrioid endometrial cancer. Antihormone therapy, such as enzalutamide may lessen the amount of androgen made by the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving enzalutamide, carboplatin, and paclitaxel may work better in treating patients with endometrioid endometrial cancer.
    Location: 6 locations

  • A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer

    The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY3023414 in combination with enzalutamide in men with prostate cancer.
    Location: 6 locations

  • Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer

    This Phase I, open-label, dose-finding, multicenter study is designed to determine the recommended Phase II dose (RP2D) for the combination of an orally administered Phosphatidylinositol-4,5-bisphosphate 3-kinase beta (PI3K-beta) inhibitor (GSK2636771) with enzalutamide. Subjects with phosphatase and tensin homolog (PTEN)-deficient metastatic castration-resistant prostate cancer (mCRPC) who are receiving a stable dose of enzalutamide with a recently demonstrated progression (either by RECIST [Response Evaluation Criteria In Solid Tumors] version 1.1, prostate-specific antigen [PSA] progression, and / or progression in bone) per the Prostate Cancer Working Group 2 (PCWG2) criteria will be enrolled. Eligible subjects will be enrolled in the Dose-Escalation Phase to determine the maximum tolerated dose (MTD) of the combination therapy using a modified 3+3 dose escalation procedure. The safety, pharmacokinetics (PK) and clinical efficacy will also be assessed to guide the selection of the RP2D. The starting dose will be GSK2636771 300 mg once daily in combination with the recommended dose (160 milligram [mg] once daily) of oral enzalutamide. Once the RP2D has been established, additional subjects will be enrolled in the Dose Expansion Phase to further evaluate the safety, PK and preliminary clinical activity. Safety assessments will be performed throughout the study including physical examinations, vital signs, clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events. Blood samples will be collected for pharmacokinetic analysis. Subjects will continue treatment until an unacceptable toxicity, disease progression, withdrawal of consent or death occurs. A post-treatment follow-up visit will be performed within 30 days of the last dose of study treatment. Xtandi is a registered trademark of Astellas Pharma Inc
    Location: 6 locations

  • Enzalutamide in Treating Patients with Advanced or Recurrent Androgen Receptor-Positive Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    This phase II trial studies how well enzalutamide works in treating patients with androgen receptor-positive ovarian, primary peritoneal, or fallopian tube cancer that has spread to nearby tissues or returned after previous treatment. Androgens can cause the growth of ovarian, primary peritoneal, or fallopian tube cancer cells. Antihormone therapy, such as enzalutamide, may block the use of androgens and slow or stop tumor growth.
    Location: 6 locations

  • A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

    The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
    Location: 5 locations

  • A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

    This is an open label, non-randomized, Phase 1b / 2a, dose escalation and dose confirmation study of ZEN003694 in combination with enzalutamide in patients with mCRPC.
    Location: 5 locations

  • Enzalutamide with or without Sorafenib Tosylate in Treating Patients with Advanced Liver Cancer

    This phase I / II trial studies the side effects and the best dose of enzalutamide when given with or without sorafenib tosylate and to see how well it works in treating patients with liver cancer (hepatocellular carcinoma) that has spread to other places in the body and usually cannot be cured or controlled with treatment. Enzalutamide binds to proteins called androgen receptors, which are found in hepatocellular carcinoma and this may keep tumor cells from growing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may also prevent the growth of new blood vessels that tumors need to grow. It is not yet known whether enzalutamide is more effective with or without sorafenib tosylate in treating patients with liver cancer.
    Location: 7 locations

  • A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

    The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
    Location: 5 locations

  • Enzalutamide with or without Ribociclib in Treating Patients with Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

    This partially randomized phase Ib / II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.
    Location: 4 locations

  • Enzalutamide and Mifepristone in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

    This partially randomized phase I / II trial studies the side effects and best dose of enzalutamide and mifepristone when given together and to see how well they work in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy, such as enzalutamide and mifepristone, may lessen the amount of androgens made by the body. It is not yet known whether enzalutamide is more effective with or without mifepristone in treating patients with prostate cancer.
    Location: 4 locations

  • Rapid Cycle Combination Therapy in Treating Patients with Metastatic Castrate-Resistant Prostate Cancer

    This phase II trial studies how well rapid cycle combination therapy works in treating patients with prostate cancer that has not responded to surgery or hormone therapy and has spread to other places in the body. Androgen can cause the growth of tumor cells. Antihormone therapy, such as abiraterone acetate and enzalutamide, may lessen the amount of androgen made by the body. Drugs used in the chemotherapy, such as radium Ra 223 dichloride, cabazitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Switching between different combinations of androgen deprivation therapy and chemotherapy after a short time may prevent drug resistance and help achieve better long-term control of prostate cancer.
    Location: 3 locations

  • Enzalutamide and DNA-PK / TOR Kinase Inhibitor CC-115 in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

    This phase Ib trial studies the side effects and best dose of deoxyribonucleic acid-dependent protein kinase (DNA-PK) / target of rapamycin (TOR) kinase inhibitor CC-115 when given together with enzalutamide in treating patients with castration-resistant prostate cancer that has spread to other places in the body. DNA-PK / TOR kinase inhibitor CC-115 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enzalutamide is an androgen receptor inhibitor that may slow down the growth of prostate cancer by blocking the action of the male hormone testosterone and other male hormones called androgens. Giving DNA-PK / TOR kinase inhibitor CC-115 and enzalutamide may work better in treating patients with castration-resistant prostate cancer.
    Location: 4 locations

  • Enzalutamide and Cabazitaxel in Treating Patients with Metastatic, Castration-Resistant Prostate Cancer

    This phase I / II trial studies the side effects and best dose of cabazitaxel when given together with enzalutamide in treating patients with prostate cancer that has spread to other places in the body (metastatic) and has not responded to treatment with hormones or no longer responds to treatment with hormones (hormone-resistant). Drugs used in chemotherapy, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Androgen can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of androgen by the tumor cells. Giving cabazitaxel together with enzalutamide may work better in treating metastatic, hormone-resistant prostate cancer.
    Location: 3 locations

  • Androgen Deprivation Therapy, Enzalutamide, and Radiation Therapy in Treating Patients with Recurrent Prostate Cancer

    This phase II trial studies how well androgen deprivation therapy, enzalutamide, and radiation therapy works in treating patients with prostate cancer that has returned. Androgens (a type of hormone) can cause the growth of prostate cancer cells. Drugs, such as those used in androgen deprivation therapy and enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving androgen deprivation therapy and enzalutamide together with radiation therapy may kill more tumor cells.
    Location: 3 locations

  • Genetic and Molecular Mechanisms in Assessing Response in Patients with Prostate Cancer Receiving Enzalutamide Therapy

    This clinical trial studies genetic and molecular mechanisms in assessing response in patients with prostate cancer receiving enzalutamide therapy. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Studying samples of tissue and blood in the laboratory from patients with prostate cancer may help doctors better understand castration-resistant prostate cancer. It may also help doctors make improvements in prostate cancer treatment.
    Location: 2 locations

  • AKT Inhibitor AZD5363 with or without Enzalutamide or Fulvestrant in Treating Patients with Advanced, Metastatic, or Recurrent Solid Tumors with AKT1, AKT2, or AKT3 Mutations

    This pilot phase I trial studies how well AKT inhibitor AZD5363 with or without enzalutamide or fulvestrant work in treating patients with solid tumors with AKT1, AKT2, or AKT3 mutations that have spread to other places in the body or have come back. AKT inhibitor AZD5363 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Prostate specific antigen or estrogen can cause the growth of tumor cells. Hormone therapy using enzalutamide or fulvestrant may fight prostate or breast cancer by blocking the use of prostate specific antigen or estrogen by the tumor cells. AKT inhibitor AZD5363 with or without enzalutamide or fulvestrant may work better in treating patients with solid tumor with AKT1, AKT2, or AKT3 mutations.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York


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