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Clarifying the Optimal Application of SLT Therapy Trial
Glaucoma and Ocular Hypertension
The goal of this study is to understand if SLT performed at low energy is as effective as
SLT performed at standard energy, and also to see if repeating SLT at low energy once a
year will prevent or delay the need for daily eye drop medications better than waiting
for SLT to wear off before repeating... expand
The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it. Type: Interventional Start Date: Sep 2021 |
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease
Von Willebrand Diseases
This is a multi-center, Phase 1a study to assess the safety, tolerability, PK, and PD of
VGA039 following single IV or SC dose administration in healthy subjects and Von
Willebrand disease patients. expand
This is a multi-center, Phase 1a study to assess the safety, tolerability, PK, and PD of VGA039 following single IV or SC dose administration in healthy subjects and Von Willebrand disease patients. Type: Interventional Start Date: Mar 2023 |
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic...
Eosinophilic Gastritis
Eosinophilic Duodenitis
Eosinophilic Gastrointestinal Disease
The study is researching an experimental drug called dupilumab. The study is focused on
participants with active eosinophilic gastritis (EoG) with or without eosinophilic
duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD
are uncommon, persistent, allergic/immune... expand
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: May 2023 |
ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery
Surgery
This protocol describes prospective, open-label, blinded, randomized controlled,
multicenter pivotal studies to evaluate ALM-488. expand
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488. Type: Interventional Start Date: Apr 2022 |
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
Immunization; Infection
Transplantation Infection
Influenza
Lung allograft recipients have a higher burden of influenza disease and greater
associated morbidity and mortality compared with healthy controls. Induction and early
maintenance immunosuppression is thought to impair immunogenicity to standard dose
inactivated influenza vaccine. This early post-transplant... expand
Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-transplant period is when immunity is most desirable, since influenza disease during this time frame is associated with adverse consequences. Thus, strategies to reduce severe influenza disease in this highly susceptible population are critical. No trials in lung transplant recipients have evaluated two doses of HD-IIV within the same influenza season as a strategy to improve immunogenicity and durability of influenza prevention. Furthermore, no influenza vaccine trials have focused on enrollment of subjects at early post-transplant timepoints. Very few studies have been performed in solely lung allograft recipients. Immunosuppression intensity is highest in lung patients, thereby limiting comparisons to recipients of heart, liver, and kidney transplants. Therefore, studies to assess both HD-IIV and two-dose strategies in the same influenza season in post-lung transplant recipients are greatly needed. The central hypothesis of our proposal is that lung allograft recipients who are 1-35 months post-transplant and receiving two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have higher HAI geometric mean titers (GMT) to influenza antigens compared to those receiving two doses of SD-QIV. To test this hypothesis and address the above critical knowledge gaps, we propose to conduct a phase II, multi-center, randomized, double-blind, controlled immunogenicity and safety trial comparing the administration of two doses of HD-QIV to two doses of SD-QIV in lung allograft recipients 1-35 months post-transplant. The results of this clinical trial will address significant knowledge gaps regarding influenza vaccine strategies (e.g., one vs. two doses and HD-QIV vs. SD-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period. Type: Interventional Start Date: Nov 2022 |
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Scoliosis Idiopathic
Early-Onset Scoliosis Deformity of Spine
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis expand
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis Type: Interventional Start Date: Feb 2021 |
The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral...
Peripheral Arterial Disease
The purpose of this study is to understand how the drug rivaroxaban improves symptoms
associated with peripheral artery disease. expand
The purpose of this study is to understand how the drug rivaroxaban improves symptoms associated with peripheral artery disease. Type: Interventional Start Date: Apr 2022 |
Gut Microbiota in Metabolic Surgery
Bariatric Surgery Candidate
Cardiovascular Diseases
Type 2 Diabetes
Dyslipidemias
Hypertension
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases
(e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can
profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical
outcomes. Longitudinal studies that examined... expand
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health. Type: Observational [Patient Registry] Start Date: Aug 2021 |
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
MDS/MPN
ABNL-MARRO (A Basket study of Novel therapy for untreated MDS/MPN and Relapsed/Refractory
Overlap Syndromes) is an international European-American cooperation providing the
framework for collaborative studies to advance treatment of
myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and explore... expand
ABNL-MARRO (A Basket study of Novel therapy for untreated MDS/MPN and Relapsed/Refractory Overlap Syndromes) is an international European-American cooperation providing the framework for collaborative studies to advance treatment of myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and explore clinical-pathologic markers of disease severity, prognosis and treatment response. ABNL MARRO 001 (AM-001) is an Open label, phase 1/2 study within the framework of the ABNL-MARRO that will test novel treatment combinations in MDS/MPN. Each Arm of AM-001 will test an active myeloid target compound in combination with ASTX727, an oral drug combining fixed doses of the DNA methyltransferase inhibitor (DNMTi) decitabine and the cytidine deaminase inhibitor E7727, also known as cedazuridine in a single tablet. Type: Interventional Start Date: Dec 2021 |
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Hemolytic-Uremic Syndrome
The objective of this study is to determine if early high volume intravenous fluid
administration (hyperhydration) may be effective in mitigating or preventing
complications of shiga toxin-producing E. coli (STEC) infection in children and
adolescents when compared with traditional approaches (conservative... expand
The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management). Type: Interventional Start Date: Sep 2022 |
Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry
Pulmonary Vascular Disease
Pulmonary Arterial Hypertension
Patients are being asked to be in this research study because medical researchers hope
that by gathering information about a large number of children with pulmonary
hypertension over time, their understanding of the disease process will increase and lead
to better treatment. Investigators believe... expand
Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences. Type: Observational [Patient Registry] Start Date: Oct 2014 |
Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Familial Pulmonary Fibrosis
Idiopathic Interstitial Pneumonia
Familial Interstitial Pneumonia
The purpose of this study is to investigate inherited genetic factors that play a role in
the development of familial pulmonary fibrosis and to identify a group of genes that
predispose individuals to develop pulmonary fibrosis. Finding the genes that cause
pulmonary fibrosis is the first step at... expand
The purpose of this study is to investigate inherited genetic factors that play a role in the development of familial pulmonary fibrosis and to identify a group of genes that predispose individuals to develop pulmonary fibrosis. Finding the genes that cause pulmonary fibrosis is the first step at developing better methods for early diagnosis and improved treatment for pulmonary fibrosis. The overall hypothesis is that inherited genetic factors predispose individuals to develop pulmonary fibrosis. Type: Observational Start Date: Jul 2008 |
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive...
Progressive Supranuclear Palsy
PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression
in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to
assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP. expand
PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP. Type: Interventional Start Date: Jul 2024 |
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
The goal of this study is to learn if GS-1427 is effective and safe in treating
participants with moderate to severe ulcerative colitis. The study will compare
participants in different treatment groups treated with GS-1427 with participants treated
with placebo (Part 1), and participants treated... expand
The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2). The primary objectives of this study are: Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12 Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12 Type: Interventional Start Date: Mar 2024 |
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to...
Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in
participants with moderately to severely active ulcerative colitis. Study 1's primary
hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the
proportion of participants achieving clinical... expand
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12. Type: Interventional Start Date: Oct 2023 |
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's...
Tourette Syndrome
The primary objective of this study is to evaluate the long-term safety and tolerability
of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12
years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age)
with Tourette's Syndrome (TS). expand
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS). Type: Interventional Start Date: Aug 2023 |
Nectero EAST System Clinical Study
Abdominal Aortic Aneurysm
The purpose of this randomized clinical trial is to treat patients with small to
mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a
locally delivered, single-dose endovascular treatment. The main question the study aims
to answer is to demonstrate efficacy of... expand
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years. Type: Interventional Start Date: Oct 2023 |
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Single Ventricle Heart Disease
This study will evaluate the clinical efficacy and safety of udenafil, an orally
administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of
adolescent who have had the Fontan procedure. expand
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure. Type: Interventional Start Date: Oct 2023 |
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans...
Recurrent Langerhans Cell Histiocytosis
Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib
(DAY101) in treating patients with Langerhans cell histiocytosis that is growing,
spreading, or getting worse (progressive), has come back (relapsed) after previous
treatment, or does not respond to therapy (refractory).... expand
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis. Type: Interventional Start Date: Mar 2024 |
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic NOH in Participants...
Symptomatic Neurogenic Orthostatic Hypotension
MSA - Multiple System Atrophy
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and
durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks
of treatment. This study includes 4 periods: Screening, open label, randomized
withdrawal, and long-term treatment extension... expand
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE). Type: Interventional Start Date: Jun 2023 |
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin...
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and
nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard
treatment alone in improving survival in patients with stage I and II classical Hodgkin
lymphoma. Brentuximab vedotin... expand
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. 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. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. 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. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone. Type: Interventional Start Date: May 2023 |
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants...
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus
on participants who have either active subacute CLE or chronic CLE, or both. They may
also have systemic lupus erythematosus (SLE).... expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: - How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? - How many participants have their skin disease activity go down by at least 70%? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: - After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. - Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. - The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. - During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. - After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. - The total study duration for participants will be up to 80 weeks Type: Interventional Start Date: Sep 2022 |
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With...
Advanced or Metastatic Colorectal Cancer
The purpose of this study is to assess the anti-tumor activity of amivantamab as a
monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added
to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer
(mCRC) (Ph2 cohorts), and to assess the... expand
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts). Type: Interventional Start Date: Jul 2022 |
Vincristine Pharmacokinetics in Infants
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
This pilot trial compares drug exposure levels using a new method for dosing vincristine
in infants and young children compared to the standard dosing method based on body
surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety
of childhood cancers. The doses anticancer... expand
This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children. Type: Observational Start Date: Nov 2022 |
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small...
Carcinoma
Non-Small-Cell Lung
Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have
progressed on treatment with Osimertinib. expand
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib. Type: Interventional Start Date: Aug 2022 |
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