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182 Clinical Trials near Danville, KY
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 PowerBHV-7000 for Epilepsy
Lexington, Kentucky
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Repetitive Seizures, Others
Must Be Taking:Antiseizure Medications
242 Participants Needed
Dostarlimab for Head and Neck Cancer
Lexington, Kentucky
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Cancers, Immunotherapy Reactions, Others
Must Not Be Taking:Anticancer, Experimental, Immunotherapy, Others
864 Participants Needed
Nivolumab + Standard Treatment for Stomach and Esophageal Cancer
Lexington, Kentucky
This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Major Surgery, Others
Must Not Be Taking:Corticosteroids, Immunosuppressives
224 Participants Needed
Nutrition Interventions for Pediatric Cancer
Lexington, Kentucky
Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxicity, inferior clinical outcomes, and increased risk of mortality. Malnutrition may progress to cancer cachexia, characterized by anorexia, increased inflammation, decreased fat, and decreased muscle mass with subsequent weight loss, which is associated with decreased overall survival.
The goal of the proposed research is to determine changes in body composition, weight status, and nutritional status between common nutrition interventions including oral nutrition supplements (ONS), appetite stimulants, and enteral nutrition (EN) among pediatric cancer patients. A secondary goal of this research is to utilize the findings to develop clinical nutrition guidelines for this patient population. The specific objective of the research proposed is to solve the lack of evidence to adequately treat nutritional deficits in the pediatric oncology population. Without this data, there is a lack of clinical consistency in the initiation and selection of appropriate nutrition interventions to provide a more definitive pathway of care. This study can help formulate a clinical guideline for this patient population before, during, and after treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:2 - 19
Key Eligibility Criteria
Disqualifiers:Enteral Nutrition, Others
Must Not Be Taking:Oral Supplements, Orexigenics
19 Participants Needed
BHV-7000 for Epilepsy
Lexington, Kentucky
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Status Epilepticus, Cluster Seizures, Others
Must Be Taking:Anti-seizure Medications
390 Participants Needed
AMX0035 for Progressive Supranuclear Palsy
Lexington, Kentucky
A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double blind placebo controlled phases, followed by an optional open-label extension phase.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Schizophrenia, Bipolar, Depression, Others
110 Participants Needed
Durvalumab + Chemotherapy for Breast Cancer
Lexington, Kentucky
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Active Autoimmune, Others
Must Not Be Taking:Live Vaccines
3680 Participants Needed
Symptom-Based Dosing for Neonatal Abstinence Syndrome
Lexington, Kentucky
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today:
1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper.
2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given.
We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:1 - 48
Key Eligibility Criteria
Disqualifiers:Major Birth Defects, Neonatal Encephalopathy, Respiratory Support, Others
480 Participants Needed
Lorundrostat for High Blood Pressure
Lexington, Kentucky
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breast-feeding, Others
Must Not Be Taking:Prohibited Medications
1400 Participants Needed
Shorter vs Usual Radiation Therapy for Prostate Cancer
Lexington, Kentucky
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
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 Prostatectomy, Others
Must Be Taking:Androgen Deprivation Therapy
1209 Participants Needed
Shorter Chemo-Immunotherapy Without Anthracyclines for Breast Cancer
Lexington, Kentucky
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Uncontrolled Diabetes, Others
Must Not Be Taking:Anti-PD-1, Anti-PD-L1
2400 Participants Needed
Faricimab Schedules for Age-Related Macular Degeneration
Lexington, Kentucky
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Dense Cataract, Pathologic Myopia, Others
Must Not Be Taking:Anti-VEGF, Corticosteroids
600 Participants Needed
Chemotherapy + Hormone Therapy for Breast Cancer
Lexington, Kentucky
This trial is testing if adding additional cancer-fighting drugs to treatments that stop certain body functions is better than just using the treatments that stop those functions alone. It targets younger women with early-stage breast cancer who have a higher risk of dying from the disease. The treatment works by stopping certain body functions and using drugs to kill cancer cells.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 60
Sex:Female
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Cardiac Disease, Others
Must Be Taking:Endocrine Therapy
3960 Participants Needed
Dostarlimab for Colon Cancer
Lexington, Kentucky
This trial is testing dostarlimab, a drug that helps the immune system fight cancer. It targets patients with a specific type of colon cancer that has certain genetic features and can be surgically removed. Dostarlimab works by helping the immune system recognize and destroy cancer cells.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Lung Disease, Cirrhosis, Others
Must Not Be Taking:Anticancer, Experimental Therapies
811 Participants Needed
Pembrolizumab for Triple-Negative Breast Cancer
Lexington, Kentucky
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Active Liver Disease, Others
Must Be Taking:Pembrolizumab
1295 Participants Needed
CagriSema for Cardiovascular Disease
Lexington, Kentucky
This trial will test if CagriSema can reduce heart attacks and strokes in people with cardiovascular disease. Participants will inject CagriSema regularly over several years. The goal is to see if CagriSema can improve heart health.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:55+
Key Eligibility Criteria
Disqualifiers:Recent Heart Attack, Stroke, Heart Failure, Others
Must Be Taking:Oral Antidiabetics, Basal Insulin
7101 Participants Needed
Heated Chemotherapy + Niraparib for Ovarian Cancer
Lexington, Kentucky
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery.
Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Low-grade Serous, Myelodysplastic, Pregnancy, Others
Must Not Be Taking:Antibiotics, Antidiabetics, Antihypertensives, Others
230 Participants Needed
Dapansutrile for Gout Flares
Lexington, Kentucky
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Tophi, Rheumatoid Arthritis, Kidney Disease, Others
Must Not Be Taking:Paracetamol, Acetaminophen, Others
300 Participants Needed
Thrombectomy + Angioplasty/Stenting for Stroke
Lexington, Kentucky
This trial tests if using a stent to open a blocked neck artery along with removing a brain clot is better than just removing the clot alone for stroke patients with severe artery blockages.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Refractory Hypertension, Intracranial Tumors, Others
Must Not Be Taking:Anticoagulants
404 Participants Needed
Shionogi Protease Inhibitor for COVID-19
Lexington, Kentucky
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
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"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
"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've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
Drug Combinations for Multiple Myeloma
Lexington, Kentucky
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Systemic Therapy, Grade 4 Neuropathy, Uncontrolled Hypertension, Others
510 Participants Needed
Gemcitabine + Docetaxel vs BCG for Bladder Cancer
Lexington, Kentucky
This trial is testing whether a combination of two drugs, Gemcitabine and Docetaxel, given directly into the bladder, is effective for patients with high-grade non-muscle invasive bladder cancer who have not been treated with the standard therapy before. The goal is to see if this new treatment can prevent cancer from coming back or spreading. The study will also look at the quality of life, safety, and side effects of the new treatment. Gemcitabine and Docetaxel have shown promise as an alternative treatment, especially in cases where the standard therapy fails or is not tolerated.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Muscle-invasive Cancer, Pregnancy, Severe Hypersensitivity, Others
870 Participants Needed
Fisetin for Meniscus Tears
Lexington, Kentucky
Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). The current randomized clinical trial will test a novel intervention after meniscal repair that combines an oral senolytic fisetin and real-time biofeedback program to restore joint loading and subsequent return to activity.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Pregnancy, Osteoarthritis, Diabetes, Depression, Others
Must Not Be Taking:Losartan, Warfarin, Opioids, Senolytics
38 Participants Needed
RYZ101 for Neuroendocrine Tumors
Lexington, Kentucky
This trial tests RYZ101, a new drug, in patients with advanced GEP-NETs that haven't responded to previous treatments. The drug aims to target specific receptors on the tumor cells to stop their growth.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Resistant Hypertension, Uncontrolled Diabetes, Others
Must Not Be Taking:High-dose Glucocorticoids
288 Participants Needed
COVID-19 Vaccine for Children
Lexington, Kentucky
This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants (3 age cohorts; 6 to \< 12 years, 2 to \< 6 years, and 6 to \< 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to \< 12 years of age).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:6 - 11
Key Eligibility Criteria
Disqualifiers:COVID-19 History, Immunodeficiency, Cancer, Others
Must Not Be Taking:COVID-19 Treatments
3600 Participants Needed
Mirvetuximab + Bevacizumab for Ovarian Cancer
Lexington, Kentucky
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
Masupirdine for Agitation in Alzheimer's Disease
Lexington, Kentucky
This trial will test a medication called masupirdine, which participants will take regularly. It targets people with Alzheimer's disease who are experiencing agitation. The study aims to see if masupirdine can help reduce agitation and ensure it is safe and well-tolerated. Masupirdine has been previously evaluated in patients with moderate Alzheimer's disease and was found to be generally safe and well-tolerated.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 90
Key Eligibility Criteria
Disqualifiers:Non-Alzheimer's Dementia, Other Psychiatric Disorder, Others
375 Participants Needed
Pegvaliase for Phenylketonuria
Lexington, Kentucky
This trial is testing pegvaliase injections in adolescents with PKU. The goal is to see if these injections are safe and effective. Pegvaliase helps the body break down a harmful substance that people with PKU cannot process on their own. Pegvaliase is a newer treatment for PKU, following earlier treatments like dietary restriction and sapropterin.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12 - 17
Key Eligibility Criteria
Disqualifiers:Organ Transplant, HIV, Hepatitis, Others
Must Not Be Taking:PKU Treatments, PEG Injectables
55 Participants Needed
Tucatinib + Trastuzumab + Chemotherapy for Colorectal Cancer
Lexington, Kentucky
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:
* mFOLFOX6 alone,
* mFOLFOX6 with bevacizumab, or
* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Systemic Therapy, Radiation, Neuropathy, Others
Must Not Be Taking:Anti-HER2 Therapy
400 Participants Needed
Chemotherapy Tailored by ctDNA Status for Colon Cancer
Lexington, Kentucky
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
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