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191 Clinical Trials near New York
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerRibociclib + Hormone Therapy for Breast Cancer
Lake Success, New York
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastases, Heart Disease, Pregnancy, Others
Must Be Taking:Endocrine Therapy
1400 Participants Needed
TAK-881 for Primary Immunodeficiency
Great Neck, New York
The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older.
The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to \[\>=\]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than \[\<\]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:2+
Key Eligibility Criteria
Disqualifiers:Hepatitis, HIV, Kidney Disease, Others
Must Be Taking:Immunoglobulin
65 Participants Needed
Inclisiran for Cardiovascular Disease Prevention
Kew Gardens, New York
This trial tests whether inclisiran injections can prevent serious heart problems in high-risk adults who haven't had a major heart event yet by lowering their cholesterol levels. Inclisiran is a long-acting treatment that significantly lowers cholesterol.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40 - 79
Key Eligibility Criteria
Disqualifiers:ASCVD, Revascularization, Liver Disease, Others
Must Be Taking:Lipid Lowering
14012 Participants Needed
Chemotherapy + Immunotherapy for Esophageal and Gastric Cancer
Flushing, New York
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Gilbert's Syndrome, Others
Must Not Be Taking:Corticosteroids, Immunosuppressants
382 Participants Needed
Ablative Therapy + Systemic Therapy for Colorectal Cancer
Flushing, New York
This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Liver-only Metastases, Unresectable Primary Tumors, Others
364 Participants Needed
Ianalumab + Corticosteroids for Low Platelet Count
Lake Success, New York
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Evans Syndrome, Coagulation Disorders, Others
Must Be Taking:Corticosteroids
226 Participants Needed
Ianalumab + Eltrombopag for Low Platelet Count
Lake Success, New York
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, Coagulation Disorders, Others
Must Be Taking:Eltrombopag
152 Participants Needed
Selinexor Maintenance Therapy for Endometrial Cancer
Rego Park, New York
The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v 1.1\]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uterine Sarcomas, Active Infection, Others
Must Not Be Taking:Systemic Steroids
276 Participants Needed
Shionogi Protease Inhibitor for COVID-19
Flushing, New York
This trial will test a new medicine called ensitrelvir to help hospitalized COVID-19 patients by stopping the virus from multiplying.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Severe Hepatic Impairment, Renal Failure, Pregnancy, Others
Must Not Be Taking:Strong CYP3A Inducers
602 Participants Needed
IST + BMT for Aplastic Anemia
New Hyde Park, New York
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant. Regular treatment for patients with aplastic anemia who have a matched sibling (brother or sister), or family donor is a bone marrow transplant. Patients without a matched family donor normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone marrow transplant (BMT) is used as a secondary treatment in patients who did not get better with IST, had their disease come back, or a new worse disease replaced it (like leukemia).
This trial will compare time from randomization to failure of treatment or death from any cause of IST versus URD BMT when used as initial therapy to treat SAA.
The trial will also assess whether health-related quality of life and early markers of fertility differ between those randomized to URD BMT or IST, as well as assess the presence of marrow failure-related genes and presence of gene mutations associated with MDS or leukemia and the change in gene signatures after treatment in both study arms.
This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for treatment of SAA.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:0 - 25
Key Eligibility Criteria
Disqualifiers:Inherited Bone Marrow Syndromes, MDS, HIV, Others
Must Not Be Taking:Androgens, Eltrombopag, Romiplostim, Others
53 Participants Needed
Efgartigimod for Myositis
Great Neck, New York
This trial is testing an injectable medication called efgartigimod PH20 SC in people with certain muscle inflammation diseases. The goal is to see if it helps improve their condition by lowering harmful proteins in their blood. The study focuses on patients with specific subtypes of these diseases who often don't respond well to usual treatments. Efgartigimod was developed for autoimmune diseases and has been approved for treating a specific muscle condition in adults.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Autoimmune Disease, Malignancy, Others
265 Participants Needed
Pitolisant for Idiopathic Hypersomnia
New Hyde Park, New York
This trial is testing the safety and effectiveness of pitolisant, a medication that helps people stay awake, in adults with idiopathic hypersomnia. These patients have already completed an earlier part of the study. Pitolisant works by boosting brain chemicals that make you feel more alert. It has been approved for the treatment of narcolepsy in adults.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Breastfeeding, ESRD, Severe Hepatic Impairment, Others
Must Not Be Taking:QT Prolonging Drugs
128 Participants Needed
Mirvetuximab + Bevacizumab for Ovarian Cancer
New York, New York
GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine + Bevacizumab as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Other Cancers, Cardiac Disease, Infections, Others
Must Be Taking:Platinum-based Chemotherapy
520 Participants Needed
Surgery and Radiation vs. Radiation Alone for Brain Cancer
Flushing, New York
This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation to target tumors and minimizes effect on normal surrounding brain tissue. The combination of surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. This study investigates whether treating with SRS before surgery may be better than SRS after surgery in reducing the possibility of the tumor coming back, reducing or preventing the cancer from spreading to other areas of the brain and reducing the risk of scarring on the brain from radiation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Cranial Radiotherapy, Leptomeningeal Disease, Germ Cell Tumor, Others
Must Not Be Taking:Cytotoxic Chemotherapy, Tyrosine Inhibitors
237 Participants Needed
Depemokimab for Hypereosinophilic Syndrome
Manhasset, New York
This trial is testing a new medication called depemokimab for adults with Hypereosinophilic Syndrome (HES) who are not responding well to their current treatments. The medication aims to lower the number of certain white blood cells that cause symptoms to worsen. Participants will either receive depemokimab or continue their usual treatment.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Infections, Cancer, Cardiovascular Disease, Others
Must Be Taking:Standard HES Therapy
123 Participants Needed
Depemokimab vs Mepolizumab for Granulomatosis with Polyangiitis
Manhasset, New York
This trial is testing two medications, depemokimab and mepolizumab, to see if they can help adults with a difficult-to-treat inflammatory condition called EGPA by reducing inflammation. Mepolizumab was previously approved for the treatment of EGPA.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Cardiovascular Disease, Immunodeficiency, Others
Must Be Taking:Oral Corticosteroids
163 Participants Needed
Chemotherapy Tailored by ctDNA Status for Colon Cancer
Valley Stream, New York
This trial tests if a blood test for cancer DNA can help decide if colon cancer patients need more treatment after surgery. The test looks for cancer DNA in the blood to predict if the cancer might come back and to guide further treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Prior Chemotherapy, Others
Must Not Be Taking:Antidepressants, Anticonvulsants
1912 Participants Needed
Remibrutinib vs Teriflunomide for Multiple Sclerosis
Lake Success, New York
This trial compares remibrutinib and teriflunomide in patients with relapsing multiple sclerosis. It aims to find out which medication is more effective and safer. Both drugs work by controlling the immune system to reduce relapses. Teriflunomide is an approved treatment for adults with this condition.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:PPMS, CNS Disease, Substance Abuse, Others
Must Not Be Taking:Leflunomide, Methotrexate, CYP3A4 Inhibitors, Others
800 Participants Needed
JDQ443 vs Docetaxel for Non-Small Cell Lung Cancer
Lake Success, New York
This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:EGFR Mutation, ALK Rearrangement, CNS Metastases, Others
Must Be Taking:Platinum-based Chemotherapy, Immune Checkpoint Inhibitors
95 Participants Needed
Hormone Therapy + Radiation for Prostate Cancer
Flushing, New York
This phase III trial uses the Decipher risk score to guide therapy selection. Decipher score is based on the activity of 22 genes in prostate tumor and may predict how likely it is for recurrent prostate cancer to spread (metastasize) to other parts of the body. Decipher score in this study is used for patient selection and the two variations of treatment to be studied: intensification for higher Decipher score or de-intensification for low Decipher score. Patients with higher Decipher risk score will be assigned to the part of the study that compares the use of 6 months of the usual treatment (hormone therapy and radiation treatment) to the use of darolutamide plus the usual treatment (intensification). The purpose of this section of the study is to determine whether the additional drug can reduce the chance of cancer coming back and spreading in patients with higher Decipher score. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Alternatively, patients with low Decipher risk score will be assigned to the part of the study that compares the use of radiation treatment alone (de-intensification) to the usual approach (6 months of hormone therapy plus radiation). The purpose of this part of the study is to determine if radiation treatment alone is as effective compared to the usual treatment without affecting the chance of tumor coming back in patients with low Decipher score prostate cancer. Radiation therapy uses high energy to kill tumor cells and reduce the tumor size. Hormone therapy drugs such as darolutamide suppress or block the production or action of male hormones that play role in prostate cancer development. Effect of radiation treatment alone in patients with low Decipher score prostate cancer could be the same as the usual approach in stabilizing prostate cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Prior Malignancy, Others
Must Not Be Taking:Hormonal Therapy, Anti-androgens
2050 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Anti-Coagulant + Anti-Platelet Therapy for Stroke Prevention
Lake Success, New York
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:30+
Key Eligibility Criteria
Disqualifiers:Intracranial Tumor, Cardiac Embolism, Others
Must Not Be Taking:Thrombolytics, Antithrombotics, CYP3A4 Inhibitors
1683 Participants Needed
Vedolizumab for Crohn's Disease
New Hyde Park, New York
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab.
The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Active Infections, Others
Must Not Be Taking:Biologics, Live Vaccines
120 Participants Needed
Vedolizumab for Ulcerative Colitis
New Hyde Park, New York
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease.
The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Active Infections, TB, Others
Must Not Be Taking:Anti-integrins, Biologics
121 Participants Needed
Depemokimab for Asthma
New Hyde Park, New York
This trial is testing a new medication called Depemokimab for people with severe asthma who have high levels of certain white blood cells. The goal is to see if switching to Depemokimab works as well as their current treatments. The medication aims to reduce these white blood cells to help control asthma symptoms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Lung Conditions, Cancer, Smoking, Others
Must Be Taking:Mepolizumab, Benralizumab
1719 Participants Needed
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis
New Hyde Park, New York
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Obstructive Airway, Cardiac Disease, Others
Must Be Taking:Pirfenidone, Nintedanib
576 Participants Needed
Rimegepant for Pediatric Migraine
New Hyde Park, New York
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Cluster Headache, Uncontrolled Psychiatric, Substance Abuse, Others
Must Be Taking:Prophylactic Migraine
2100 Participants Needed
Etavopivat for Sickle Cell Disease
New Hyde Park, New York
This trial is testing a drug called etavopivat to see if it can help people with sickle cell disease. The drug aims to improve blood health and reduce pain by making red blood cells work better. The study includes patients aged 12 to 65.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12 - 65
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B/C, Renal Dysfunction, Others
Must Not Be Taking:Voxelotor, Erythropoietin, CYP3A4/5 Inducers
450 Participants Needed
Topical Antibiotics for Surgical Site Infection
Queens, New York
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Infection, Myonecrosis, Pregnancy, Others
Must Not Be Taking:Vancomycin, Aminoglycosides
1550 Participants Needed
Hormone + Radiation Therapy for Prostate Cancer
Flushing, New York
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Seizure Disorder, Others
Must Be Taking:Hormone Therapy
2753 Participants Needed
Rucaparib + Enzalutamide for Prostate Cancer
Flushing, New York
This randomized, placebo-controlled phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Seizure History, Others
Must Be Taking:Androgen Deprivation
61 Participants Needed
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