
Search Clinical Trials
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Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Post Traumatic Stress Disorder
Opioid-use Disorder
The overall objective of the proposed study is to determine if lofexidine (LFX) as an
adjunct to buprenorphine (BUP) treatment improves symptoms of both opioid use disorder
(OUD) and Post-Traumatic Stress Disorder (PTSD). Other study objectives are to compare
the safety, tolerability, and efficacy1 expand
The overall objective of the proposed study is to determine if lofexidine (LFX) as an adjunct to buprenorphine (BUP) treatment improves symptoms of both opioid use disorder (OUD) and Post-Traumatic Stress Disorder (PTSD). Other study objectives are to compare the safety, tolerability, and efficacy of BUP treatment alone, to BUP treatment with adjunct LFX, on measures of OUD and PTSD symptoms in Veterans with both prognosis . Type: Interventional Start Date: Mar 2021 |
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NE3107 in Adults With Neurological Symptoms of Long COVID
BioVie Inc.
Long COVID
Long COVID is a condition where debilitating symptoms can persist for months after a
COVID-19 infection. This study aims to evaluate the effects of NE3107 on several
neurological symptoms reported in people with Long COVID including difficulty
concentrating or remembering things ("brain fog") and f1 expand
Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection. This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things ("brain fog") and fatigue. Researchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID. Participants will: - Take NE3107 or a placebo twice daily for 84 days - Visit the clinic 5 times for checkups and tests and have a follow up phone call Type: Interventional Start Date: Apr 2025 |
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Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
The University of Texas Health Science Center at San Antonio
Parkinson Disease
This study aims to determine the effects of aerobic exercise as a primer to add-on
virtual reality (VR)-based rehabilitation on balance, postural control and
neuroplasticity (ability of brain to adapt in structure and function) in individuals with
Parkinson's disease (PD). This study will utilize t1 expand
This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment). Type: Interventional Start Date: Feb 2024 |
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Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
The University of Texas Health Science Center at San Antonio
Atrophy of Muscle Due to Disuse
Rehabilitation
This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral
leg disuse (Phase 1), immediately followed by 1 week of bilateral leg rehabilitation
(Phase 2). The investigators will recruit cohorts of healthy middle-aged men and women to
address their aims:
- Demonstrat1 expand
This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral leg disuse (Phase 1), immediately followed by 1 week of bilateral leg rehabilitation (Phase 2). The investigators will recruit cohorts of healthy middle-aged men and women to address their aims: - Demonstrate the sex-specific effects of skeletal muscle disuse (Phase 1) - Identify key molecular determinates of susceptibility of skeletal muscle atrophy (Phase 1) - Map the early, sex-specific molecular time-course of rehabilitation (Phase 2) - Determine if disused and healthy muscle respond similarly to exercise (Phase 2) Healthy, middle-age men and post-menopausal women (50-65 years) will be recruited from the greater Houston/Galveston area. This under-represented research demographic demonstrate few negative metabolic or phenotypic signs of advanced age, but are at increased risk of being hospitalized and experiencing accelerated loss of lean mass and muscle function that parallels a much older population. The goal of this study is to characterize phenotypic and molecular skeletal muscle changes in middle-aged men and women during critical periods of disuse and rehabilitation and ultimately direct the development of targeted and effective prevention and treatment strategies. Type: Interventional Start Date: Aug 2021 |
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Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Pr1
Plus Therapeutics
Glioma
This is an open-label, multicenter, Phase 1 study to establish the safety and
efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via
intraventricular catheter) for recurrence glioma in patients who received a prior
treatment of 186RNL. expand
This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL. Type: Interventional Start Date: Dec 2024 |
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Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
The University of Texas Health Science Center at San Antonio
Carcinoma, Hepatocellular
This is an observational, prospective cohort study that will recruit a diverse sample of
84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma
(HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment
tools with participants 65 yea1 expand
This is an observational, prospective cohort study that will recruit a diverse sample of 84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma (HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment tools with participants 65 years and older and collects adverse events and exploratory markers of aging for all participants. Type: Observational Start Date: Sep 2019 |
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Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymp1
Children's Oncology Group
B Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
Lymphoblastic Lymphoma
Mixed Phenotype Acute Leukemia
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy
versus (vs.) standard chemotherapy alone in protecting the liver in patients with
leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the
treatment of acute lymphoblastic leukem1 expand
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy versus (vs.) standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients. Type: Interventional Start Date: Aug 2023 |
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A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metas1
Tvardi Therapeutics, Incorporated
Hepatocellular Carcinoma
The primary objectives of Cohort A Phase 1b are to evaluate the safety and tolerability
of TTI-101 orally administered as a single agent to participants with locally advanced or
metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum
tolerated dose (MTD) and/or reco1 expand
The primary objectives of Cohort A Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent to participants with locally advanced or metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of TTI-101 as a single agent. The primary objectives of Cohort A Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 as a single agent in participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohort A Phase 2 are to assess response, progression, survival, and pharmacokinetics. The primary objectives of Cohorts B and C Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, or unresectable HCC and to determine the MTD and/or RP2D of TTI-101 when used in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C). The primary objectives of Cohorts B and C Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohorts B and C Phase 2 are to assess response, progression, survival, and pharmacokinetics. Type: Interventional Start Date: Mar 2023 |
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Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer
The University of Texas Health Science Center at San Antonio
Lung Neoplasm
Create a living biobank of PDOs from Stage I-III lung cancer patients. expand
Create a living biobank of PDOs from Stage I-III lung cancer patients. Type: Observational Start Date: Oct 2018 |
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Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (1
The University of Texas Health Science Center at San Antonio
Alcohol Use Disorder
This study is testing a new treatment called IR-TMS (image-guided, robot navigated
transcranial magnetic stimulation) to see if it can help people who drink too much
alcohol to reduce the amount they drink. Participants will be placed into one of three
groups, each receiving a slightly different ve1 expand
This study is testing a new treatment called IR-TMS (image-guided, robot navigated transcranial magnetic stimulation) to see if it can help people who drink too much alcohol to reduce the amount they drink. Participants will be placed into one of three groups, each receiving a slightly different version of this treatment. The study involves going through a few sessions of IR-TMS, having brain scans (MRI), providing blood and urine samples, and answering questions about their drinking and mental health. These activities are part of the study and aren't usually part of regular treatment for alcohol use. IR-TMS is different from regular treatments like therapy or medication because it uses magnetic fields to target specific parts of the brain. The goal is to see if this treatment can help reduce the urge to drink. There are other options, like sticking with therapy or medication, which are less intense but have been used for a longer time. Type: Interventional Start Date: Feb 2025 |
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Genomic Predictors of Recurrent Pregnancy Loss
Yale University
Recurrent Pregnancy Loss
The overall goals of this proposal are to determine the genetic architecture of recurrent
pregnancy loss (RPL) and to discover genomic predictors of RPL. expand
The overall goals of this proposal are to determine the genetic architecture of recurrent pregnancy loss (RPL) and to discover genomic predictors of RPL. Type: Observational Start Date: Sep 2021 |
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Chromosome 18 Clinical Research Center
The University of Texas Health Science Center at San Antonio
Chromosome Aberrations
Growth Hormone Deficiency
Hypomyelination
Our vision, that of the researchers at the University of Texas Health Science Center at
San Antonio, is that every person with a chromosome 18 abnormality will have an
autonomous and healthy life. Our mission is to provide families affected by chromosome 18
abnormalities with comprehensive medical1 expand
Our vision, that of the researchers at the University of Texas Health Science Center at San Antonio, is that every person with a chromosome 18 abnormality will have an autonomous and healthy life. Our mission is to provide families affected by chromosome 18 abnormalities with comprehensive medical and educational information. Our goals are to provide definitive medical and education resources for the families of individuals with chromosome 18 abnormalities; perform and facilitate groundbreaking clinical and basic research relating to the syndromes of chromosome 18; and to provide treatments to help these individuals overcome the effects of their chromosome abnormality. Type: Observational Start Date: Sep 1993 |
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Study in Parkinson Disease of Exercise
Northwestern University
Parkinson Disease
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance
treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease
Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage
Parkinson disease. 370 participants will1 expand
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise. Type: Interventional Start Date: Aug 2021 |
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Prevention of Progression of Prediabetes, Obesity and CV Risk
The University of Texas Health Science Center at San Antonio
Pre-Diabetes
Weight, Body
Cardiovascular Diseases
The investigators are studying how to help people with prediabetes (Pre-DM) and obesity.
The goal is to use new and affordable treatments to bring blood sugar levels back to
normal and help participants to lose weight. The investigators also want to reduce
participants risk of heart problems. The s1 expand
The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future. Type: Interventional Start Date: Sep 2024 |
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Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical1
SeaStar Medical
Acute Kidney Injury
This randomized, controlled, pivotal study is intended to determine whether up to ten
sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve
survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney
replacement therapy (CKRT) when compared to C1 expand
This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT. Type: Interventional Start Date: Apr 2023 |
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Effects of Emicizumab vs. Factor VIII Prophylaxis on Joint and Bone Health in Severe Hemophilia A
Washington Institute for Coagulation
Hemophilia A
The investigators propose to study longitudinal joint and bone density changes in
patients with severe Hemophilia A. Per current standard of care, most patients are on
prophylactic FVIII replacement therapy intravenously several times weekly with a goal of
keeping the trough >1% FVIII. Recent phase1 expand
The investigators propose to study longitudinal joint and bone density changes in patients with severe Hemophilia A. Per current standard of care, most patients are on prophylactic FVIII replacement therapy intravenously several times weekly with a goal of keeping the trough >1% FVIII. Recent phase 3 data suggest superior bleed protection with emicizumab prophylaxis every 1-2 weeks. It is the purpose of this study to longitudinally assess joint health and bone density over 3 years and to compare the effect of routine factor VIII prophylaxis with emicizumab prophylaxis. Type: Observational Start Date: Apr 2019 |
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LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
NovoCure GmbH
Metastatic Non-small Cell Lung Cancer
This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using
TTFields, delivered by the NovoTTF-200T device, concomitantly administered with
pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell
lung cancer that has spread to other parts1 expand
This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer. Type: Interventional Start Date: Jul 2024 |
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De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence1
NRG Oncology
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy. expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
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Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®
The University of Texas Health Science Center at San Antonio
Tooth Extraction
After the removal of a tooth, a bone graft is often placed in the socket to try to keep
the volume of bone that was there when the tooth was present so that the bone does not
"shrink". The bone graft is sometimes kept in place with a small piece of material over
the top of the tooth socket and with1 expand
After the removal of a tooth, a bone graft is often placed in the socket to try to keep the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is sometimes kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation including bone allografts (bone grafts derived from a human tissue donor), bone xenografts (bone grafts derived from species other than humans, such as cows and pigs), and synthetic materials that are similar in structure to bone (such as calcium apatite). The bone allograft and the calcium apatite product used in this study are Food and Drug Administration (FDA) approved. This study will compare the two methods used to see how much new bone formation there is inside the tooth socket at about 16 weeks of healing after ridge preservation with a calcium apatite/collagen sponge versus an allograft. Type: Interventional Start Date: Nov 2025 |
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Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer Wi1
The University of Texas Health Science Center at San Antonio
Breast Cancer Metastatic
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6
inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast
cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6
inhibitor and hormonal therapy. expand
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6 inhibitor and hormonal therapy. Type: Interventional Start Date: Oct 2025 |
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Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cance1
ECOG-ACRIN Cancer Research Group
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
This study examines the impact of social and genetic factors on outcomes in adolescent
and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to
both older adult and childhood cancer patients, AYAs with cancer experience different
diagnoses and specific biological, clin1 expand
This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment morbidity and premature death. Collecting samples of blood samples and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma may help doctors identify conditions that increase the likelihood of AYAs getting sick and dying after treatment of cancer and better understand how to address the needs of adolescent and young adult cancer survivors. Type: Observational Start Date: Oct 2023 |
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Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to1
SWOG Cancer Research Network
Grade 3b Follicular Lymphoma
High Grade B-Cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
This phase 2 trial studies the side effects and best dose of tazemetostat and
zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these
combinations work in treating patients with large B-cell lymphoma that returned or did
not respond to earlier treatment. Tazemetosta1 expand
This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back. Type: Interventional Start Date: Sep 2023 |
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Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and1
M.D. Anderson Cancer Center
Lymphoma
To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients
before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is
easily collected from blood samples drawn using the vein puncture method. expand
To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method. Type: Interventional Start Date: Feb 2023 |
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Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast1
Stemline Therapeutics, Inc.
Breast Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
This is a multi-site, global, open-label study that includes a phase 1b evaluation of
elacestrant in combination with abemaciclib in women and men with brain metastases from
estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2)
negative breast cancer. Phase 1b was design1 expand
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer. Type: Interventional Start Date: Aug 2022 |
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Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients W1
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm
This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib
works to shrink tumors in patients with solid tumors that are unlikely to be cured or
controlled with treatment and that may have spread from where it first started to nearby
tissue, lymph nodes, or distant parts1 expand
This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Another aim of this study is to find out if, and how, patients' genes influence their response to this specific drug combination. For this part of the study, investigators will run tests using samples of patients' tumor tissue and blood that will be collected during the study. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Genes are pieces of the DNA code that individuals inherit from their parents. Some genes work to protect against cancer by correcting damage that can occur in the DNA when cells divide. BRCA1 and BRCA2 are two examples of these types of genes, and they are called tumor-suppressor genes. For example, if a person has a mutation in a BRCA1/2 gene they have a greatly increased risk of developing breast and ovarian cancer because their cells may no longer be able to completely repair damaged DNA. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Other genes are also involved in this process, and these are called DNA damage repair genes. The KRAS mutation is a change in a protein in normal cells. Normally KRAS serves as an information hub for signals in the cell that lead to cell growth, but when there is a mutation in KRAS it signals too much and cells grow without being told to, which causes cancer. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer. Type: Interventional Start Date: Nov 2022 |