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197 Clinical Trials near Charlotte, NC
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 PowerIST + BMT for Aplastic Anemia
Charlotte, North Carolina
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
Ketamine vs Fentanyl for Traumatic Injury Pain Management
Charlotte, North Carolina
The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:No IV Access, Age <18, Others
994 Participants Needed
Rifaximin for Bloating in Cystic Fibrosis
Charlotte, North Carolina
This trial is testing rifaximin, an antibiotic, to help people with cystic fibrosis who have gut symptoms like bloating. The antibiotic works by balancing gut bacteria to reduce discomfort. Rifaximin has been used to treat travelers' diarrhea and other conditions, and it has shown effectiveness in reducing symptoms of irritable bowel syndrome (IBS).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Advanced Lung Disease, Advanced Liver Disease, Pregnancy, Others
Must Not Be Taking:Oral Antibiotics
100 Participants Needed
Chemotherapy for Rhabdomyosarcoma
Charlotte, North Carolina
This trial uses chemotherapy drugs to treat patients with very low-risk and low-risk rhabdomyosarcoma. The goal is to maintain good outcomes while reducing treatment intensity. The study also examines if patients with specific DNA mutations benefit from more intensive therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:< 21
Key Eligibility Criteria
Disqualifiers:Prior Chemotherapy, Radiation, Uncontrolled Infection, Others
Must Not Be Taking:CYP3A4 Inhibitors, Inducers
205 Participants Needed
Olvi-Vec + Chemotherapy for Ovarian Cancer
Charlotte, North Carolina
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:CNS Metastasis, HIV, Hepatitis, Others
Must Not Be Taking:Antivirals, Immunosuppressants, Steroids
186 Participants Needed
Depemokimab vs Mepolizumab for Granulomatosis with Polyangiitis
Charlotte, North Carolina
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
Remibrutinib vs Teriflunomide for Multiple Sclerosis
Charlotte, North Carolina
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
NRTX-1001 Neural Cell Therapy for Epilepsy
Charlotte, North Carolina
This trial tests if injecting special brain cells into the brain can help patients with hard-to-treat epilepsy. The new cells release a calming chemical to reduce seizures. Patients will also take medicines to prevent their bodies from rejecting the new cells.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Neurologic Disease, Immunodeficiency, Psychiatric Disorders, Others
Must Be Taking:ASDs
88 Participants Needed
Saroglitazar Magnesium for Primary Biliary Cholangitis
Charlotte, North Carolina
This trial tests Saroglitazar Magnesium tablets on patients with Primary Biliary Cholangitis to see if it can help their liver work better and reduce inflammation.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Chronic Hepatitis B Or C, Cirrhosis, Unstable Cardiovascular Disease, Uncontrolled Thyroid Disorder, Others
Must Be Taking:Ursodeoxycholic Acid
186 Participants Needed
Anti-Coagulant + Anti-Platelet Therapy for Stroke Prevention
Charlotte, North Carolina
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
Combination Chemotherapy for Rhabdomyosarcoma
Charlotte, North Carolina
This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 50
Key Eligibility Criteria
Disqualifiers:Uncontrolled Infection, CNS Involvement, Others
Must Not Be Taking:CYP3A4 Inhibitors, Inducers
118 Participants Needed
Hormone Therapy with or without Radiation for Breast Cancer
Charlotte, North Carolina
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 70
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Mastectomy, Non-breast Malignancies, Others
Must Be Taking:Endocrine Therapy
1670 Participants Needed
Nivolumab + Chemo-Immunotherapy for Large B-Cell Lymphoma
Charlotte, North Carolina
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2+
Key Eligibility Criteria
Disqualifiers:Heart Disease, Infection, Autoimmune, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
244 Participants Needed
Rimegepant for Pediatric Migraine
Charlotte, North Carolina
This trial aims to test the safety of rimegepant, a medication for treating migraines. The study focuses on children and adolescents aged 6 to 17 years who experience moderate to severe migraines. Rimegepant works by blocking a protein that triggers migraine pain, helping to alleviate symptoms.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Cluster Headache, Hemiplegic Migraine, Others
Must Be Taking:Prophylactic Migraine
600 Participants Needed
177Lu-PSMA-617 + Standard Therapy for Prostate Cancer
Charlotte, North Carolina
This trial tests if adding a radioactive drug to standard hormone treatments can better treat men with advanced prostate cancer. The drug targets and kills cancer cells with radiation, while standard treatments block hormones that help cancer grow.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiac Disease, Others
Must Be Taking:Androgen Therapy
1145 Participants Needed
Denosumab to Prevent Breast Cancer in Women With BRCA1 Mutation
Charlotte, North Carolina
This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:25 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bilateral Mastectomy, Ovarian Cancer, Breast Cancer, Invasive Cancer, Others
Must Not Be Taking:Tamoxifen, Raloxifene, Aromatase Inhibitors
300 Participants Needed
Rimegepant for Pediatric Migraine
Charlotte, North Carolina
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
Charlotte, North Carolina
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
Charlotte, North Carolina
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
Natural vs Programmed Frozen Embryo Transfer for Pregnancy
Charlotte, North Carolina
NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 41
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, Hypertension, Others
Must Not Be Taking:Chronic Systemic Medications
788 Participants Needed
Why Other Patients Applied
"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
"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
Hormone + Radiation Therapy for Prostate Cancer
Charlotte, North Carolina
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
T-DM1 + Tucatinib for Breast Cancer
Charlotte, North Carolina
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV Cancer, Hepatitis B/C, Others
Must Be Taking:Taxane, Trastuzumab
1056 Participants Needed
Tildrakizumab for Psoriatic Arthritis
Charlotte, North Carolina
This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Hepatitis B/C, HIV, Others
Must Be Taking:Anti-TNF Agents
510 Participants Needed
Tildrakizumab for Psoriatic Arthritis
Charlotte, North Carolina
This trial is testing tildrakizumab, a medication that reduces inflammation, in patients with active Psoriatic Arthritis who haven't tried certain other treatments. It works by blocking a protein to help manage symptoms. Tildrakizumab is approved for treating moderate to severe plaque psoriasis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Uncontrolled Disease, Active Malignancy, Recent Heart Issues, Others
296 Participants Needed
CPX-351 + Gilteritinib for Acute Myeloid Leukemia
Charlotte, North Carolina
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:< 21
Key Eligibility Criteria
Disqualifiers:Not Listed
1186 Participants Needed
Atezolizumab + Radiation Therapy for Lung Cancer
Charlotte, North Carolina
This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Autoimmune Disease, Others
Must Not Be Taking:Corticosteroids, Immunosuppressive Agents
480 Participants Needed
Osimertinib + Bevacizumab for Lung Cancer
Charlotte, North Carolina
This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiovascular Disease, Hypertension, Interstitial Lung Disease, Others
Must Not Be Taking:Anti-VEGF Agents, CYP3A4 Inducers
300 Participants Needed
MRI Monitoring vs. Preventive Brain Radiation for Small Cell Lung Cancer
Charlotte, North Carolina
This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Severe Hepatic Disease, Others
668 Participants Needed
Stereotactic Radiosurgery for Brain Metastasis
Charlotte, North Carolina
This trial compares two radiation treatments for patients with brain cancer that has spread and been surgically removed. One treatment uses a single session of radiation, while the other uses several sessions. The goal is to see which method is more effective and has fewer side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Whole Brain Radiation, Germ Cell Tumor, Lymphoma, Leptomeningeal Metastasis, Others
242 Participants Needed
Red Blood Cell Exchange for Sickle Cell Disease
Charlotte, North Carolina
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:RBC Alloimmunization, Hyper-hemolysis, Severe Transfusion Reaction, Others
173 Participants Needed
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