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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 Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory...
Pfizer
Myositis
The purpose of the study is to understand how the study medicine PF-06823859 works in
people with idiopathic inflammatory myopathies (DM and PM). These disorders cause
inflammation that weakens the muscles that are important for movement and may also cause
skin rash in people with DM.
This study... expand
The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: - Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater - Have active DM or active PM. - Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. - Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site. Type: Interventional Start Date: May 2023 |
Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with...
Boundless Bio
Non-small Cell Lung Cancer
Non-Small Cell Lung Adenocarcinoma
Non-Small Cell Squamous Lung Cancer
Head and Neck Squamous Cell Carcinoma
Esophageal Cancer
BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule
inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx).
This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety
profile and identify the maximum tolerated... expand
BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies. Type: Interventional Start Date: Mar 2023 |
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone...
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
marker... 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 |
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-...
Janssen Research & Development, LLC
Ischemic Stroke; Ischemic Attack, Transient
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke. expand
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke. Type: Interventional Start Date: Feb 2023 |
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Mirati Therapeutics Inc.
Advanced NSCLC
Metastatic Lung Cancer
Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical
efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the
first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C
mutation expand
Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation Type: Interventional Start Date: Nov 2022 |
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants...
Kite, A Gilead Company
High-risk Large B-cell Lymphoma (LBCL)
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel,
versus standard of care (SOC) in first-line therapy in participants with high-risk large
B-cell lymphoma. expand
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma. Type: Interventional Start Date: Feb 2023 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease...
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) developed... 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, Bortezomib...
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 therapy... 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 |
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC)
in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in
combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination
with pomalidomide and dexamethasone... expand
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Type: Interventional Start Date: Oct 2022 |
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome
National Cancer Institute (NCI)
Colorectal Carcinoma
Lynch Syndrome
This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent
colon and other cancers in participants with Lynch syndrome. Each of the three injections
in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells.
Injecting these substances may cause... expand
This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancers in participants with Lynch syndrome. Each of the three injections in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells. Injecting these substances may cause the immune system to develop a defense against cancer that recognizes and destroys any precancer and cancer cells that produce these proteins in the future. N-803 may increase immune responses to other vaccines. Giving Tri-Ad5 in combination with immune enhancing N-803 may lower the chance of developing colon and other cancers in participants with Lynch syndrome. Type: Interventional Start Date: May 2023 |
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
Bristol-Myers Squibb
Colitis, Ulcerative
The purpose of this study is to explore the safety, efficacy, effects on quality of life
(QOL), and biomarker response of ozanimod in participants with moderate to severely
active ulcerative colitis (UC) in clinical practice. expand
The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice. Type: Interventional Start Date: Jan 2023 |
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants...
Novartis Pharmaceuticals
Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.)
ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in
combination with SoC, in adult participants with active LN expand
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN Type: Interventional Start Date: Jul 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 |
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With...
Xencor, Inc.
Metastatic Castration-Resistant Prostate Cancer
This Phase 2 study will investigate the safety and clinical activity of vudalimab
(XmAb20717) alone or in combination with standard of care anticancer therapies in
patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed
on prior therapy. expand
This Phase 2 study will investigate the safety and clinical activity of vudalimab (XmAb20717) alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior therapy. Type: Interventional Start Date: Oct 2021 |
Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient
University of Kansas Medical Center
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
To determine if use of Moses 2.0 results in improved ablation efficiency during holmium
laser vaporization of the prostate. To determine if use of Moses 2.0 results in less
char, improved visibility, and improved hemostasis in prostate vaporization. expand
To determine if use of Moses 2.0 results in improved ablation efficiency during holmium laser vaporization of the prostate. To determine if use of Moses 2.0 results in less char, improved visibility, and improved hemostasis in prostate vaporization. Type: Interventional Start Date: Nov 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 |
Mitigating the Pro-inflammatory Phenotype of Obesity
University of Kansas Medical Center
Blood Pressure
Diabetes
Obesity
Insulin Resistance
Diuretics Drug Reactions
The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve
activity (SNA) inhibition (oral clonidine) will cause a significant reduction in
circulating blood concentrations and endothelial cell expression of inflammatory markers
(e.g., TNF-α, IL-6).
Our study is a... expand
The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6). Our study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo. Type: Interventional Start Date: Jul 2021 |
Reversing Glucose and Lipid-mediated Vascular Dysfunction
University of Kansas Medical Center
Blood Pressure
Hypertension
The purpose of our study is to understand the extent to which the blood vessels are
affected by glucose and fat (lipids) in lean healthy adults and if these changes in the
blood vessels contribute to the development of high blood pressure. expand
The purpose of our study is to understand the extent to which the blood vessels are affected by glucose and fat (lipids) in lean healthy adults and if these changes in the blood vessels contribute to the development of high blood pressure. 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 |
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
University of Kansas Medical Center
Prostate Cancer
Lower Urinary Tract Symptoms
To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of
lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course
for patients concurrently diagnosed with prostate cancer. expand
To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer. Type: Interventional Start Date: Sep 2019 |
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 cancer... 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 |
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML)...
National Cancer Institute (NCI)
Acute Myeloid Leukemia
This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and
venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in
treating older and unfit patients with acute myeloid leukemia and FLT3 mutations.
Azacitidine is a drug that is absorbed into... expand
This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach. Type: Interventional Start Date: Sep 2024 |
Rural Alliance for Diabetes Prevention
University of Kansas Medical Center
PreDiabetes
The purpose of this randomized controlled trial is to compare the effectiveness of
Cooperative Extension implementing two delivery methods (group video vs. self-directed)
and participant recruitment strategies of the National Diabetes Prevention Program (NDPP)
to adults in rural communities. Exploratory... expand
The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas. Type: Interventional Start Date: Jul 2024 |
RESET-Myositis: an Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with...
Cabaletta Bio
Idiopathic Inflammatory Myopathy
Dermatomyositis
Anti-Synthetase Syndrome
Immune-Mediated Necrotizing Myopathy
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Subjects with Active 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 Type: Interventional Start Date: Dec 2023 |
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