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Genetic Testing in Guiding Treatment for Patients With Brain Metastases
Alliance for Clinical Trials in Oncology
CDK Gene Mutation
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
NTRK Family Gene Mutation
PI3K Gene Mutation
This phase II trial studies how well genetic testing works in guiding treatment for
patients with solid tumors that have spread to the brain. Several genes have been found
to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C.
Medications that target these genes... expand
This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib, entrectinib and adagrasib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation. Type: Interventional Start Date: Aug 2019 |
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Impulse Dynamics
Heart Failure
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized,
single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of
care. Patients to be included will have NYHA functional class III symptoms and a left
ventricular ejection fraction of 25-45% expand
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45% Type: Observational [Patient Registry] Start Date: Jan 2020 |
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed...
National Cancer Institute (NCI)
Anaplastic Astrocytoma
Anaplastic Astrocytoma, Not Otherwise Specified
Anaplastic Ganglioglioma
Anaplastic Pleomorphic Xanthoastrocytoma
Glioblastoma
This phase II trial studies how well the combination of dabrafenib and trametinib works
after radiation therapy in children and young adults with high grade glioma who have a
genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill
tumor cells and reduce the size of... expand
This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma. Type: Interventional Start Date: Feb 2020 |
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic...
Juno Therapeutics, a Subsidiary of Celgene
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Small Lymphocytic
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety
of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will
include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in
subjects with relapsed or refractory CLL or... expand
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated. Type: Interventional Start Date: Nov 2017 |
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive...
Alliance for Clinical Trials in Oncology
Intracranial Meningioma
Recurrent Meningioma
NF2 Gene Mutation
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor
GSK2256098, and capivasertib work in treating patients with meningioma that is growing,
spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098,
capivasertib, and abemaciclib may stop the... expand
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Type: Interventional Start Date: Aug 2015 |
Project: Every Child for Younger Patients With Cancer
Children's Oncology Group
Adrenal Gland Pheochromocytoma
Carcinoma In Situ
Central Nervous System Neoplasm
Childhood Immature Teratoma
Childhood Langerhans Cell Histiocytosis
This study gathers health information for the Project: Every Child for younger patients
with cancer. Gathering health information over time from younger patients with cancer may
help doctors find better methods of treatment and on-going care. expand
This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care. Type: Observational Start Date: Nov 2015 |
Global Prospective, Observational Cohort of Adult Patients with Primary Sclerosing Cholangitis (WIND-PSC...
PSC Partners Seeking a Cure
PSC
Develop an appropriate real-world data comparator cohort to support the design,
execution, and serve as an external control for interventional clinical trials in PSC. expand
Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC. Type: Observational Start Date: May 2024 |
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Vedanta Biosciences, Inc.
Clostridium Difficile
Clostridium Difficile Infections
Clostridium Difficile Infection Recurrence
Clostridioides Difficile Infection
Clostridioides Difficile Infection Recurrence
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the
Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who
receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are
identical for Stage 1 (recurrent CDI) and... expand
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI). Type: Interventional Start Date: May 2024 |
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors
Immuneering Corporation
Advanced Solid Tumor (Phase 1)
Pancreas Adenocarcinoma
Non-small Cell Lung Cancer
Malignant Melanoma (Cutaneous)
This is a FIH, ascending dose study to characterize the safety, tolerability, optimal
dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or
metastatic solid tumors harboring RAS or RAF oncogenic mutations. expand
This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations. Type: Interventional Start Date: Feb 2024 |
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Massachusetts General Hospital
Electronic Cigarette Use
The goal of this study is to conduct a pilot randomized waitlist-controlled trial to
assess the feasibility, acceptability, and preliminary effects of substituting the NIDA
standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not
ready to quit smoking. A waitlist controlled... expand
The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day [primary outcome], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control [WLC]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC). Type: Interventional Start Date: Jun 2024 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation...
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low... expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
Nutrition for Precision Health, Powered by the All of Us
RTI International
Nutrition
Health
Dietary Habits
The goal of this investigational study is to develop algorithms that predict human
response to foods. The main question it aims to answer are:
- How does varying foods and eating patterns impact one's biological and physiological
responses?
- In what ways can novel dietary assessment... expand
The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: - How does varying foods and eating patterns impact one's biological and physiological responses? - In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? - Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: - Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. - Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. - Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured. Type: Interventional Start Date: Apr 2023 |
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination with Pembrolizumab in Participants with...
GV20 Therapeutics
Solid Tumor, Adult
Refractory Cancer
Endometrial Carcinoma (EC)
Squamous Head and Neck Carcinoma
PMMR/MSS Adenocarcinoma of the Colon or Rectum
This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants
with advanced solid tumors, who are refractory to approved therapies or other standard of
care. expand
This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care. Type: Interventional Start Date: Mar 2023 |
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal...
Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy
This registry evaluates patient characteristics, real-world treatment patterns, and
short- and long-term outcomes in a population of patients in the United States and Europe
with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving
mavacamten, receiving other treatment for obstructive... expand
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Type: Observational [Patient Registry] Start Date: Aug 2022 |
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal...
Kardium Inc.
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System
for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). expand
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). Type: Interventional Start Date: Mar 2023 |
Study of MGY825 in Patients With Advanced Non-small Cell Lung Cancer
Novartis Pharmaceuticals
Non-small Cell Lung Cancer
Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer. expand
Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer. Type: Interventional Start Date: Oct 2022 |
Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Center for International Blood and Marrow Transplant Research
Acute Myeloid Leukemia in Remission
Prospective determination of the clinical utility of measurable residual disease (MRD)
testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing
allogeneic hematopoietic cell transplantation (alloHCT). expand
Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT). Type: Observational Start Date: Aug 2022 |
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid...
Relay Therapeutics, Inc.
PIK3CA Mutation
Solid Tumor, Adult
HER2-negative Breast Cancer
Breast Cancer
Metastatic Breast Cancer
This is an open-label, FIH study designed to evaluate the maximum tolerated dose,
recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary
antineoplastic activity of RLY-2608, in advanced solid tumor patients with a
Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic... expand
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors, RLY-2608 + fulvestrant and RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) combination arms for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2). 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 carrying... 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 |
TRISCEND II Pivotal Trial
Edwards Lifesciences
Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
Heart Valve Diseases
Cardiovascular Diseases
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid
valve replacement system expand
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system Type: Interventional Start Date: Apr 2021 |
Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or...
MapKure, LLC
Solid Tumor
B-Raf Mutation-Related Tumors
The purpose of this study is to evaluate the safety, tolerability, and antitumor activity
of BGB-3245 in participants with advanced or refractory solid tumors expand
The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory solid tumors Type: Interventional Start Date: Feb 2020 |
Trial of Parkinson's and Zoledronic Acid
California Pacific Medical Center Research Institute
Parkinson Disease
Osteoporosis
Parkinsonism
Parkinson's Disease and Parkinsonism
Atypical Parkinsonism
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion
of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60
years and older with Parkinson's disease and parkinsonism with at least 2 years of
follow-up. A total of 3500 participants... expand
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. Type: Interventional Start Date: Nov 2019 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitation... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Type: Interventional Start Date: Nov 2018 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
National Cancer Institute (NCI)
Advanced Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Stage IV Lung Non-Small Cell Cancer AJCC v7
This phase II trial studies how well osimertinib works in treating patients with
non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or
has come back after a period of improvement (recurrent). Osimertinib may stop the growth
of tumor cells by blocking some of the... expand
This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Type: Interventional Start Date: Apr 2018 |
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