
Search Clinical Trials
Sponsor Condition of Interest |
---|
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
National Cancer Institute (NCI)
Advanced Solid Tumors
Metastatic Pancreatic Cancer
Pediatric Solid Tumor
Advanced Breast Cancer
Malignant Peripheral Nerve Sheath Tumor
Background:
Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90%
of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers
hope a new drug can help. It stops cancer cells from growing and spreading further and
possibly shrink cancer1 expand
Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs. Objective: To find a safe dose of metarrestin and to see if this dose shrinks tumors. Eligibility: Adults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options. Design: Participants will be screened with: - blood tests - physical exam - documentation of disease confirmation or tumor biopsy - electrocardiogram to evaluate the heart - review of their medicines and their ability to do their normal activities Participants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary. Participants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body. Adult participants may have tumor biopsies. Participants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends. Type: Interventional Start Date: Oct 2020 |
Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advan1
Abbott Medical Devices
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pulmonary Hypertension
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the
HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of
ambulatory advanced heart failure patients who are not dependent on intravenous inotrope. expand
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope. Type: Interventional Start Date: Dec 2024 |
A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelina1
Sanofi
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Polyneuropathy, Inflammatory Demyelinating, Chronic
The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in
adult participants with CIDP whose disease is refractory to standard of care. The study
duration will be for a maximum of 109 weeks including screening, treatment phases, and
follow-up. expand
The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. Type: Interventional Start Date: Jul 2024 |
A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Modera1
Amgen
Sjögren's Syndrome (SS)
Primary Objective:
To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants
with moderate-to-severe symptom state
Secondary Objectives:
1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in
participants with SS.
2. To evaluate t1 expand
Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS Type: Interventional Start Date: Apr 2024 |
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550 (study 1305-0014 or
1305-0023).
The goal of this study is t1 expand
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550 (study 1305-0014 or 1305-0023). The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests. Type: Interventional Start Date: Sep 2024 |
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Re1
GluBio Therapeutics Inc.
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and
expansion clinical study of GLB-001 in participants with relapsed or refractory acute
myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk
myelodysplastic syndromes (R/R HR-MDS). Th1 expand
Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The dose escalation part (Phase 1a) of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 administered orally. Approximately 24 participants (up to 42 participants) may be enrolled in Phase 1a of the study. The dose expansion part (Phase 1b) will be followed to understand the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Up to 24 participants (12 participants per dose level) may be enrolled in Phase 1b of the study. Type: Interventional Start Date: Jan 2024 |
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressi1
Sanofi
Multiple Sclerosis
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is
to determine the efficacy of frexalimab in delaying the disability progression and the
safety up to 36 months double-blind administration of study intervention compared to
placebo in male and female participan1 expand
The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. - The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome1
Amgen
Sjogren's Syndrome
Primary Objective:
To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome
(SS) in participants with moderate-to-severe systemic disease activity.
Secondary Objectives:
1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in
participa1 expand
Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. To evaluate the safety and tolerability of dazodalibep in participants with SS Type: Interventional Start Date: Jan 2024 |
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
NRG Oncology
Breast Cancer
Cognitive Impairments
This Phase III trial will examine the efficacy of computerized cognitive training methods
on perceived cognitive impairment in breast cancer survivors. expand
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors. Type: Interventional Start Date: Apr 2024 |
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With1
Bayer
Biochemically Recurrent Prostate Cancer
Researchers are looking for a better way to treat men at high-risk of biochemical
recurrence (BCR) of prostate cancer.
BCR means that in men who had prostate cancer and were treated by either surgery and/ or
radiation therapy, the blood level of a specific protein called PSA rises. PSA is a
marker1 expand
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Type: Interventional Start Date: Apr 2023 |
Safety and Efficacy of NMD670 in Ambulatory Adult Patients With Type 3 Spinal Muscular Atrophy
NMD Pharma A/S
Spinal Muscular Atrophy
The purpose of this study is to evaluate the efficacy, safety, tolerability and
pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular
atrophy type 3 expand
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular atrophy type 3 Type: Interventional Start Date: Sep 2023 |
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Janssen Research & Development, LLC
Atrial Fibrillation
The purpose of this study is to evaluate if milvexian is at least as effective as
apixaban for reducing the risk of the composite stroke and non-central nervous system
(CNS) systemic embolism. expand
The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism. Type: Interventional Start Date: Apr 2023 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Proteas1
University of Minnesota
COVID-19
Treatments are needed to improve outcomes among patients hospitalized for COVID-19,
including direct-acting antiviral (DAA) agents to mitigate the pathology driven by
ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an
anti-SARS-CoV2 3C-like protease inhibitor (PI) develo1 expand
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Type: Interventional Start Date: Dec 2022 |
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezo1
Celgene
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy and safety of mezigdomide
(CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and
dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM)
who received between 1 to 3 prior lines of the1 expand
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Type: Interventional Start Date: Sep 2022 |
Comparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients1
NRG Oncology
Advanced Head and Neck Squamous Cell Carcinoma
Advanced Hypopharyngeal Squamous Cell Carcinoma
Advanced Laryngeal Squamous Cell Carcinoma
Advanced Oropharyngeal Squamous Cell Carcinoma
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
This phase II/III trial compares whether cisplatin given weekly with radiation therapy is
better tolerated than cisplatin given every three weeks with radiation therapy for the
treatment of head and neck cancer that has spread to other places in the body (advanced).
The second part of this study wi1 expand
This phase II/III trial compares whether cisplatin given weekly with radiation therapy is better tolerated than cisplatin given every three weeks with radiation therapy for the treatment of head and neck cancer that has spread to other places in the body (advanced). The second part of this study will also help to find out if the cisplatin given weekly approach will extend patients' life by at least the same amount of time as the cisplatin given every three weeks approach. Cisplatin is in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Radiation with low-dose cisplatin given weekly may be effective in shrinking or stabilizing head and neck cancer or preventing its recurrence. Type: Interventional Start Date: Feb 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
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. expand
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. Type: Interventional Start Date: Aug 2022 |
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
Poseida Therapeutics, Inc.
Multiple Myeloma
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1
allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory
Multiple Myeloma (RRMM). expand
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM). Type: Interventional Start Date: May 2022 |
Pan Tumor Rollover Study
Bristol-Myers Squibb
Cancer
Main Objective of this study is to examine long-term safety of nivolumab monotherapy
including combinations and other cancer therapies in various tumor types. expand
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types. Type: Interventional Start Date: Aug 2019 |
Study of ATX-01 in Participants with DM1
ARTHEx Biotech S.L.
Myotonic Dystrophy 1
The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy
type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well
tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching
placebo.
There will be a single-ascending1 expand
The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated. The trial will compare the safety and tolerability of ATX-01 and a matching placebo. There will be a single-ascending dose part of the trial and a multiple-ascending dose part. In the single-ascending dose, participants will receive one dose of ATX-01 or placebo. In the multiple-ascending dose part, participants will receive three doses of ATX-01 or placebo. ATX-01 is a novel anti-miR (synthetic single stranded oligonucleotide) that inhibits a microRNA called miR-23b. Type: Interventional Start Date: Oct 2024 |
Obsidio™ Conformable Embolic Registry
Boston Scientific Corporation
Hypervascular Tumors
Bleeding
Hemorrhage
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry
of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of
this Registry is to assess effectiveness and safety outcomes of subjects who undergo
embolization with Obsidio. expand
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio. Type: Observational [Patient Registry] Start Date: Jun 2024 |
A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carc1
Tempus AI
Head and Neck Squamous Cell Carcinoma
The study is a prospective, longitudinal, non-interventional, multicenter study of
participants with HNSCC who will have tissue and blood based molecular biomarker
profiling during their standard of care treatment. expand
The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment. Type: Observational [Patient Registry] Start Date: Aug 2024 |
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects Wit1
Cabaletta Bio
Idiopathic Inflammatory Myopathy
Dermatomyositis
Anti-Synthetase Syndrome
Immune-Mediated Necrotizing Myopathy
Juvenile Dermatomyositis
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory
Myopathy expand
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy Type: Interventional Start Date: Dec 2023 |
A Study About Antibody Levels and Biomarkers in the Blood in People With Late-onset Pompe Disease
Astellas Gene Therapies
Pompe Disease (Late-onset)
Pompe disease is a genetic condition which causes muscle weakness over time. People with
Pompe disease have a faulty gene that makes an enzyme called acid alpha-glucosidase (or
GAA). This enzyme breaks down a type of sugar called glycogen. Without this enzyme, there
is a build-up of glycogen in the1 expand
Pompe disease is a genetic condition which causes muscle weakness over time. People with Pompe disease have a faulty gene that makes an enzyme called acid alpha-glucosidase (or GAA). This enzyme breaks down a type of sugar called glycogen. Without this enzyme, there is a build-up of glycogen in the cells of the body. This causes muscle weakness and other symptoms. Pompe disease can happen at any age, but in late-onset Pompe disease, symptoms generally start from 12 months old onwards. The standard treatment for people with Pompe disease is to receive regular infusions of the GAA enzyme. This is known as enzyme replacement therapy. However, people can build up antibodies against the GAA enzyme over time. Gene therapy is used to treat conditions caused by a faulty gene. It works by replacing the faulty gene with a working gene inside the cells of the body. The working gene is delivered into the cells using certain viruses as carriers (vectors). Viruses are often used as carriers as they can easily get inside cells. The genetic material of the original virus is replaced with the working gene, so only the working gene gets inside the cells. A common virus used as a carrier in gene therapy is the adeno-associated virus (or AAV). This is like an adenovirus, which causes the common cold. The original type of AAV does not cause any harm to humans. However, people that have previously been infected with the original type of AAV may have built up antibodies against AAV. These antibodies may stop the AAV carrier with the working gene getting inside the cells. Researchers want to learn more about antibody levels against AAV and the GAA enzyme in people with late-onset Pompe disease. They also want to learn about other substances in the blood that provide more information about late-onset Pompe disease. These are known as biomarkers. In this study, older teenagers and adults with late-onset Pompe disease will take part. They will not have had gene therapy using AAV. There will be 2 groups - those who have never had enzyme replacement therapy, and those who have had enzyme replacement therapy for 6 months or more. No study treatment will be given during the study, but blood and urine samples will be taken for testing. The main aims of the study are to check antibody levels against AAV8 (a type of AAV) in people with late-onset Pompe disease who had not received any treatment using AAV, to check antibody levels against the GAA enzyme in people previously treated with GAA as part of enzyme replacement therapy, to check levels of biomarkers for Pompe disease, and to check for medical problems. In the study, people will visit the study clinic several times. Some visits may be in the person's home. The first visit is to check if they can take part. Those who can take part will have a medical examination, and have their vital signs checked. Vital signs include blood pressure, heart rate, breathing rate and temperature. Blood samples will be taken to check antibody levels against the GAA enzyme and against AAV8. Blood and urine samples will also be taken to check for biomarkers for Pompe disease. Blood and urine samples will be taken about every 4 months for up to 2 years. Type: Interventional Start Date: Feb 2024 |
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab1
National Cancer Institute (NCI)
Metastatic Colorectal Adenocarcinoma
Recurrent Colorectal Adenocarcinoma
Refractory Colorectal Adenocarcinoma
Stage IV Colorectal Cancer AJCC v8
This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in
combination with cetuximab and encorafenib in treating patients with colorectal cancer
that has not responded to previous treatment (refractory), that has come back after a
period of improvement (relapsed), and that h1 expand
This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins. When ZEN003694 binds to BET proteins, it disrupts gene expression. Preventing the expression of certain growth-promoting genes may inhibit proliferation of tumor cells that over-express BET proteins. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Encorafenib is an enzyme inhibitor. It inhibits pathways that are responsible for controlling cell proliferation and survival, which may lead to a decrease in tumor cell proliferation. Both cetuximab and encorafenib have been approved to treat cancer. Adding ZEN003694 to cetuximab and encorafenib may be more effective at treating patients with refractory metastatic colorectal cancer than giving the usual treatment (cetuximab and encorafenib) alone. Type: Interventional Start Date: Jun 2024 |
Safety and Tolerability of Ziftomenib Combinations in Patients with Relapsed/Refractory Acute Myelo1
Kura Oncology, Inc.
AML
AML with Mutated NPM1
Hematologic Malignancy
KMT2Ar
NPM1 Mutation
The safety, tolerability, and antileukemic response of ziftomenib in combination with
standard of care treatments for patients with relapsed/refractory acute myeloid leukemia
will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and
gilteritinib. expand
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib. Type: Interventional Start Date: Feb 2024 |
- Previous
- Next