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 57
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  • 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

  • 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 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: 10 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

  • 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

  • Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer

    This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2) The Dose Escalation phase will evaluate the safety and tolerability of GS-5829 as a single agent and in combination with enzalutamide, as well as determine the maximum tolerated dose (MTD) of GS-5829 as a single agent and in combination with enzalutamide in participants with metastatic castrate-resistant prostate cancer (mCRPC). The Dose Expansion phase will evaluate the following: - In group 1, the efficacy of GS-5829 as a single agent in participants with mCRPC who have progressed while receiving enzalutamide (may have also received abiraterone) - In group 2, the efficacy of GS-5829 combined with enzalutamide in participants with mCRPC who have progressed while receiving treatment with abiraterone (may not have previously received enzalutamide) - In group 3, the efficacy of GS-5829 combined with enzalutamide in participants with mCRPC who have had Prostate Specific Antigen (PSA) progression, but not radiographic progression, while receiving treatment with enzalutamide (participants may have also previously received abiraterone)
    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

  • 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

  • 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: 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, dose escalation and dose confirmation study of ZEN003694 in combination with enzalutamide in patients with mCRPC.
    Location: 5 locations

  • A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

    The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.
    Location: 7 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 of Rucaparib Verses 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 verses treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
    Location: 4 locations

  • Enzalutamide with or without Ribociclib in Treating Patients with Metastatic Hormone-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 prostate cancer that does not respond to treatment with hormones (hormone resistant), 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

  • Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resistant Prostate Cancer

    The study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic CRPC, including approved agents (e.g., abiraterone, enzalutamide) as well as investigational agents for mCRPC that have proven to show efficacy and can be combined based on complimentary mechanism of action. As a first step, the combination of GSK525762 will be evaluated as a combination with abiraterone or enzalutamide in men with metastatic or advanced castrate-resistant prostate cancer who have progressed on at least one line of prior androgen receptor (AR)-targeted therapy. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B). Arm A and Arm B will further have 2 cohorts: A1, A2 and B1, B2 respectively based on prior lines of therapy (L2 [chemo-naive subjects treated with a second androgen-deprivation therapy] and Lx [subjects treated with both prior androgen-deprivation therapy and chemotherapy]). During dose escalation, both the treatment arms (A and B) will follow a modified Toxicity Probability Interval (mTPI) design. Approximately 130 subjects will be enrolled worldwide in this study. Subjects from both dose escalation and dose expansion may be combined to reach 30 subjects. The total duration of study will be approximately 2 to 3 years. A subject will be considered to have completed the study if they are followed until death.
    Location: 4 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

  • 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

  • Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365 / KEYNOTE-365)

    The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.
    Location: 3 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: 5 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 (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

  • BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)

    The overall aim of the trial is to investigate the safety and anti-tumour activity of an experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide, compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients that have previously been treated and failed on docetaxel and abiraterone treatments. Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide that can be taken together. Once the MTD, or recommended phase II dose, have been determined an expansion cohort will also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose, of BI 836845 and enzalutamide determined in the phase Ib escalation phase. The randomised trial (phase II) will be an open label, parallel group study design in a 1:1 ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the MTD / recommended doses, or enzalutamide alone (Arm B). In all parts of the trial safety, anti-tumour activity will be assessed, in addition to circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and determination of Overall Survival (OS).
    Location: 2 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

  • 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: 3 locations


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