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Displaying 1 - 20 of 889

A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Contact: Kimberly Kelly
Investigator:
Randolph Hecht

Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)

The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.

Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Kimberly Kelly
Open Actively Recruiting

Identification of imaging-based biomarkers for Chronic Low Back Pain

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: WENXIN WEI
Investigator:
EVANGELIA TSOLAKI
Open Actively Recruiting

First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Lisa Yonemoto
Open Actively Recruiting

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jessica Jenkins
Investigator: Lara Ray, PhD, MA
Open Actively Recruiting

Global Prospective Case Series Using a Single-Use Duodenoscope

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

Phase: N/A
Primary Purpose: Other
Gender: All
Contact: Nazish Zafar
Open Actively Recruiting

First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: CINDY TONG
Open Actively Recruiting

A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma

This phase III trial compares the effect of vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide for the treatment of high risk rhabdomyosarcoma. Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vinorelbine and VAC may kill more tumor cells. Adding maintenance therapy (vinorelbine and cyclophosphamide) after VAC therapy, with or without vinorelbine, may help get rid of the cancer and/or lower the chance that the cancer comes back.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Children
Contact: Mikayla Marvis Henderson
Open Actively Recruiting

Simultaneous multinuclear Na+/H+ Metabolic MRI to Characterize Critical Brain Tissue Ischemia

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: All
Contact: ANTHONY WANG
Investigator:
Benjamin Ellingson
Open Actively Recruiting

Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients

AOC 1001-CS1 is a randomized, double-blind, placebo-controlled, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple-doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) patients (MARINA).

Part A is a single dose design with 1 cohort (dose level). In Part A, the patient duration is 6 months as the treatment period is 1 day followed by a 6 month follow-up period. Part B is a multiple-ascending dose design with 3 cohorts (dose levels). In Part B, the patient duration is 6 months as the treatment period is 3 months followed by a 3 month follow-up period.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Contact: Emilie Douine
Open Actively Recruiting

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: GINA KHACHATRIAN
Open Actively Recruiting

IMPACT OF HIV ON GUT-ASSOCIATED LYMPHOID TISSUE (GALT)

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Contact: Irma Franco-Gonzalez
Open Actively Recruiting

Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study

This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.

Phase: N/A
Primary Purpose: Prevention
Gender: All
Age Group: Children
Contact: Mikayla Marvis Henderson
Open Actively Recruiting

An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.

Gender: All
Age Group: Adults
Contact: Halah Mansour
Open Actively Recruiting

Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)

Participants will be randomized in a 2:1 ratio to receive either two injections of CMV-MVA Triplex® or placebo administered at study Entry/Day 0 and week 4.

Vaccine Group: 60 participants will receive CMV-MVA Triplex® containing 5 x 10^8 plaque-forming unit (pfu) ±0.5 x 10^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections. Placebo Group: 30 participants will receive a volume of placebo (7.5% Lactose in phosphate-buffered saline [PBS]) that matches the volume of the active vaccine injection by IM deltoid injections.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Contact: Irma Franco-Gonzalez
Open Actively Recruiting

A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment

This study is open to adults with diabetic macular ischemia who have received laser treatment. The main purpose of this study is to find out whether people with diabetic macular ischemia can tolerate a medicine called BI 765128.

In this study, BI 765128 is given to people for the first time. The study has 2 parts. Part A tests 3 doses of BI 765128. Participants get either a low, medium or high dose of BI 765128 as a single injection into the eye. If participants tolerate it well, the highest dose will be used in part B. In part B, participants are put into 2 groups randomly, which means by chance. 1 group gets BI 765128 as injection into the eye. The other group gets sham injections. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. In this part, participants receive study treatment once every month for 3 months. Participants in part A are in the study for about 4 months and visit the study site about 8 times. Participants in part B are in the study for about 5 months and visit the study site about 7 times. The doctors regularly check participants' health and take note of any unwanted effects.

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Contact: Connie Zhen
Open Actively Recruiting

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma

This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of AVB-S6-500 in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. The phase 1b portion of the study is open label and patients will receive AVB-S6-500, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of AVB-S6-500, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.

Phase: Phase I/II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Lisa Yonemoto
Open Actively Recruiting

Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma

This is a 2-part multicenter Phase 1b study designed to test icapamespib in patients with recurrent brain lesions.

Part 1 of the trial will be a standard 3 by 3 dose escalation design where different doses are examined. Part 2 will be a dose expansion cohort to further evaluate the recommended Phase 2 dose (RP2D). The RP2D is defined as the dose level recommended for further clinical study, or the highest dose tested.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: QUAN LI
Open Actively Recruiting

Phenotyping Chronic Low-Back Pain and Mapping Connectivity of Brain using fMRI , electrophysiology, radiograph, and questionnaires in Adults

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: JULIA CHANG
Open Actively Recruiting

Use of Multi-modal (MMHealth) Remote Audio and Video Sensing for Estimation of Physiological Vital Signs in Hospitalized and Non-Hospitalized Patients

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: All
Contact: LALEH JALILIAN