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Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine The1
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with es1 expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Aug 2023 |
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gas1
CinDome Pharma, Inc.
Diabetic Gastroparesis
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone)
can help reduce the symptoms associated with diabetic gastroparesis in adult patients.
The main questions it aims to answer are:
- To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when giv1 expand
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients. The main questions it aims to answer are: - To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo - To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo Participants will go through the following schedule: - Screening period (1-2 visits) - Lead-in period (1 visit) - Will complete a Gastric Emptying Breath Test (GEBT) - Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation - 12-week treatment period (7 visits) - Study drug taken twice daily by mouth - Will complete daily diaries and other PROs as described in protocol - 1 week follow-up (1 visit) Researchers will compare the effects of the following treatments: - Drug- CIN-102 Dose 15 mg or 10 mg - Drug- Placebo Type: Interventional Start Date: Mar 2023 |
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Com1
Alliance for Clinical Trials in Oncology
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
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 antibodie1 expand
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. Type: Interventional Start Date: Jun 2023 |
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
Edwards Lifesciences
Heart Failure
This is a prospective, multi-center, randomized, sham-controlled, double-blinded
(participant and outcomes assessor) clinical trial. expand
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial. Type: Interventional Start Date: Apr 2023 |
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Xenon Pharmaceuticals Inc.
Primary Generalized Tonic-Clonic Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). expand
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). Type: Interventional Start Date: Feb 2023 |
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard1
National Cancer Institute (NCI)
Acute Myeloid Leukemia
Myelodysplastic Syndrome
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a
screening tool and specific laboratory tests to help improve participants' ability to
register to clinical trials throughout the course of their myeloid cancer (acute myeloid
leukemia or myelodysplastic syndrom1 expand
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP). Type: Interventional Start Date: Jun 2024 |
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Stud1
AC Immune SA
Alzheimer's Disease
Prodromal Alzheimer's Disease
Amyloid Plaque
Beta-Amyloid
Alzheimer's Disease in Down Syndrome
The purpose of this study is to assess the safety, tolerability, immunogenicity and
pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and
in non-demented adults with Down syndrome. expand
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome. Type: Interventional Start Date: Jun 2022 |
A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Can1
Astellas Pharma Global Development, Inc.
Gastric Adenocarcinoma
Gastroesophageal Junction (GEJ) Adenocarcinoma
Pancreatic Adenocarcinoma
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It
is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help
control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune
cell called a T-cell. This "tel1 expand
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments. The main aims of the study are: - To check the safety of ASP2138 and how well people can tolerate medical problems during the study. - To find a suitable dose of ASP2138 to be used later in the study. - These are done for ASP2138 given by itself and when given together with the standard cancer treatments. Adults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a "trigger" such as infection, or have a specific heart condition ("New York Heart Association Class III or IV"). Phase 1: Lower to higher doses of ASP2138 - ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection). - Different small groups are given lower to higher doses of ASAP2138. - ASP2138 is either given by itself, or given with 1 of 3 standard treatments: - Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer) - Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer) - ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer) Phase 1b: doses of ASP2138 worked out from Phase 1 - ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1. - People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1. - This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments. - The standard cancer treatments given depends on the type of cancer they have. End of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment. People who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself. Type: Interventional Start Date: Jun 2022 |
DMCRN-02-001: Assessing Pediatric Endpoints in DM1
Virginia Commonwealth University
Congenital Myotonic Dystrophy
CDM
The overall goal of the study is to establish valid clinical endpoint assessments for
children with congenital myotonic dystrophy type 1 and develop biomarkers for the
condition. expand
The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and develop biomarkers for the condition. Type: Observational Start Date: Aug 2022 |
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multip1
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) expand
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Type: Interventional Start Date: Dec 2021 |
Pancreatic Cancer Early Detection Consortium
Arbor Research Collaborative for Health
Pancreas Cancer
Pancreas Cyst
Pancreatic Ductal Adenocarcinoma
Genetic Predisposition
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct
research on multiple aspects of early detection and prevention of pancreatic ductal
adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family
history of PDAC and/or individuals carrying1 expand
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up. Type: Observational Start Date: Sep 2020 |
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymp1
Celgene
Lymphoma, B-Cell
This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or
CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The
dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab,
Cyclophosphamide, Doxorubicin, Vinc1 expand
This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined. Type: Interventional Start Date: Sep 2021 |
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated Wit1
enGene, Inc.
Superficial Bladder Cancer
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
This study will evaluate the safety and efficacy of intravesical administration of EG-70
in the bladder and its effect on bladder tumors in patients with NMIBC.
This study study consists of two phases; a Phase 1 dose-escalation to establish safety
and recommended the phase 2 dose, followed by a Ph1 expand
This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated. Type: Interventional Start Date: Apr 2021 |
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
Johns Hopkins University
Chronic Obstructive Pulmonary Disease Severe
Chronic Bronchitis
A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study
to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or
alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per
week, or alternate regimen) to prevent hospi1 expand
A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per week, or alternate regimen) to prevent hospitalization or death in a patients at high risk for COPD exacerbations. Type: Interventional Start Date: Feb 2020 |
Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)
Virginia Commonwealth University
Myotonic Dystrophy 1
DM1
Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN),
the present study seeks to overcome insufficient data on natural history; lack of
reliable biomarkers; and incomplete characterization and limited biological understanding
of the phenotypic heterogeneity of Myoto1 expand
Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward. Funding Source- FDA OOPD Type: Observational Start Date: Jan 2019 |
Head Positioning After Retina Detachment Repair
University of Kansas Medical Center
Retina; Detachment, Rhegmatogenous
This study aims to determine if one day post-operative prone head positioning can be as
good as seven days post-operative prone head positioning in patients with retinal
detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV)
using perfluoropropane (C3F8) gas as a tampo1 expand
This study aims to determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. The investigator will conduct a single arm phase II study using a Simon's two-stage design Type: Interventional Start Date: Apr 2019 |
Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep
University of Kansas Medical Center
Insomnia
Adolescent
Digital Health
The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our
study team to co-design a beta-test a new prototype of the Firefly program, a
mobile-native insomnia cognitive behavioral therapy intervention for teens. This new
prototype will have addressed issues that adole1 expand
The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment. Type: Observational Start Date: Apr 2025 |
A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unres1
Coherus Biosciences, Inc.
Hepatocellular Carcinoma
The main goals of this study are to evaluate the safety and efficacy of casdozokitug in
combination with toripalimab plus bevacizumab and to define a recommended dose for
casdozokitug in combination with toripalimab plus bevacizumab. expand
The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab. Type: Interventional Start Date: Dec 2024 |
A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants1
BeiGene
Metastatic Solid Tumors
Advanced Non-squamous Non-small-cell Lung Cancer
Advanced Colorectal Cancer
Advanced Pancreatic Ductal Adenocarcinoma
Advanced Gastric Cancer
This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose
expansion study to evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in
participants with advanced or metastatic solid tumors ha1 expand
This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion. Type: Interventional Start Date: Nov 2024 |
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Mul1
Opna Bio LLC
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics,
preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in
combination with dexamethasone in subjects with relapsed and/or refractory MM. expand
Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM. Type: Interventional Start Date: Aug 2024 |
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
Astellas Pharma Inc
Solid Tumor
Genes contain genetic code which tell the body which proteins to make. Some types of
cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are
looking for ways to stop the actions of abnormal proteins made from the mutated KRAS
gene. The so-called G12D mutation in the KRAS1 expand
Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors. ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396. In this study, ASP4396 is being given to humans for the first time. People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments. The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396. This study will be in 2 parts. Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2. Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies. In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment. People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished. People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not. After treatment has finished, people in the study will be followed up for up to 45 weeks. Type: Interventional Start Date: Apr 2024 |
Platform Clinical Study for Conquering Scleroderma
Scleroderma Research Foundation, Inc.
Interstitial Lung Disease Due to Systemic Disease
Scleroderma
The goal of this clinical trial is to test efficacy of different investigational products
(IPs) compared with placebo on the change from baseline to the end of the treatment
period at Week 52 in lung capacity in participants with Interstitial Lung Disease
Secondary to Systemic Sclerosis. expand
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis. Type: Interventional Start Date: Apr 2024 |
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in1
Incyte Corporation
Myeloproliferative Neoplasms
This study is being conducted to evaluate the safety, tolerability, dose-limiting
toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s)
for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With
Ruxolitinib in participants with myelopro1 expand
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms. Type: Interventional Start Date: Dec 2023 |
Brain Outcomes With Lifestyle Change in Down Syndrome
University of Kansas Medical Center
Down Syndrome
Alzheimer Disease
Obesity
The goal of this study is to determine if weight loss or changes in dietary intake can
help prevent of delay adults with Down syndrome from developing Alzheimer's Disease
Adults with Down syndrome without dementia will be randomized to either a weight loss
group or a general health education contr1 expand
The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease Adults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics. All participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake. Type: Interventional Start Date: Oct 2024 |
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capeci1
National Cancer Institute (NCI)
Metastatic Colorectal Carcinoma
Metastatic Malignant Solid Neoplasm
Stage IV Colorectal Cancer AJCC v8
Unresectable Colorectal Carcinoma
Unresectable Malignant Solid Neoplasm
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in
combination with the usual treatment with capecitabine in treating patients with cancer
that has spread from where it first started (primary site) to other places in the body
(metastatic) or cannot be removed by surger1 expand
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors. Type: Interventional Start Date: Nov 2023 |
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