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NCT ID: NCT04776018 Terminated - Clinical trials for Relapsed and/or Refractory Multiple Myeloma (RRMM)

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)

Start date: April 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies (mAbs) to treat participants who have relapsed or refractory multiple myeloma (RRMM). The main aims of the study are to evaluate the safety and efficacy of TAK-981 in combination with anti-CD38 (mAbs) and to determine the recommended Phase 2 dose (RP2D). Participants will be on this combination treatment for 28-day cycles. They will continue with this treatment until disease progression or unacceptable toxicity.

NCT ID: NCT04775953 Completed - Clinical trials for Staphylococcal Bacteraemia

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

Start date: April 22, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded, superiority study. The study will compare dalbavancin to standard of care antibiotic therapy for the completion of therapy in patients with complicated bacteremia or right-sided native valve Infective Endocarditis (IE) caused by S. aureus who have cleared their baseline bacteremia. Approximately 200 subjects will be randomized 1:1 to receive either dalbavancin or a standard of care antibiotic regimen that is based upon the identification and antibiotic susceptibility pattern of the baseline organism. Subjects randomized to the dalbavancin treatment group will receive 2 doses of dalbavancin intravenously (IV) 1 week apart (1500 mg on Day 1 and Day 8 after randomization, with renal dose adjustment if appropriate). Subjects randomized to the standard of care antibiotic therapy treatment group will receive an antibiotic regimen considered to be standard of care based on the methicillin susceptibility pattern of the pathogen isolated at baseline for a duration of 4 to 6 weeks and up to 8 weeks for patients with vertebral osteomyelitis/discitis. The primary objective is to compare the Desirability of Outcome Ranking (DOOR) at Day 70 of dalbavancin to that of standard of care antibiotic therapy used to consolidate therapy for the treatment of subjects with complicated S. aureus bacteremia in the intent-to-treat population (ITT).

NCT ID: NCT04775797 Terminated - Chronic Hepatitis Clinical Trials

Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

Start date: June 25, 2021
Phase: Phase 1
Study type: Interventional

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

NCT ID: NCT04775719 Active, not recruiting - Clinical trials for Patient Satisfaction

Pilot Sensor Randomized Controlled Trial: Setting Expectations to Increase Satisfactory Outcomes After Total Knee Replacement

SensorRCT
Start date: August 16, 2021
Phase: N/A
Study type: Interventional

More than 70,000 total knee replacement procedures are performed annually in Canada, representing a growth of 17% over the past 5 years, with further increases anticipated due to an aging population. While total knee replacement offers improved quality of life for patients and is cost effective for the healthcare system, 20% of patients routinely report dissatisfaction with the procedure. Patient dissatisfaction has been strongly linked to unmet expectations of outcomes after the surgery, especially with respect to physical activity. Counselling patients on appropriate expectations has been suggested as a means to improve satisfaction. Recently, our group has developed a tool to predict the functional ability of an individual patient after total knee replacement. This tool employs machine learning to classify patients as more likely to maintain or improve function, based on a functional test performed in clinic while wearing a sensor system around each knee. Implementing this tool in clinic pre-operatively could assist in setting appropriate expectations for each patient. Our primary objective is to compare patient satisfaction scores at one year after total knee replacement in patients who were informed of their specific expected functional outcome compared to patients who were not informed of their predicted functional outcome. We hypothesize that patients who are given an informed expectation will have higher satisfaction scores. This in turn may decrease health system costs associated with additional clinic visits from dissatisfied patients.

NCT ID: NCT04775485 Recruiting - Clinical trials for Advanced Solid Tumor

A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

FIREFLY-1
Start date: April 22, 2021
Phase: Phase 2
Study type: Interventional

FIREFLY-1 is an ongoing, Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known RAF alteration.

NCT ID: NCT04774718 Recruiting - Clinical trials for ALK Fusion-positive Solid or CNS Tumors

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

Start date: September 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.

NCT ID: NCT04774380 Active, not recruiting - Clinical trials for Extensive-stage Small Cell Lung Cancer

Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer

LUMINANCE
Start date: November 11, 2021
Phase: Phase 3
Study type: Interventional

Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.

NCT ID: NCT04774159 Recruiting - Inflammation Clinical Trials

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

LEADER-PAD
Start date: May 6, 2021
Phase: Phase 3
Study type: Interventional

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

NCT ID: NCT04773782 Recruiting - CNS Tumor Clinical Trials

A Study of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

Start date: February 24, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multicenter, open-label trial of avapritinib in participants 2 to < 18 years of age with advanced relapsed/refractory (R/R) solid tumors, including central nervous system (CNS) tumors, that harbor a PDGFRA and/or KIT mutation (including non-synonymous point mutations, insertions, and deletions) or amplification, or DMG-H3K27a who have no available curative treatment options. This is a single-arm trial in which all participants will receive avapritinib. The study consists of 2 parts: dose confirmation, safety, and PK (Part 1) and initial efficacy, safety, and PK at the Part 2 recommended dose (Part 2).

NCT ID: NCT04773665 Completed - Covid19 Clinical Trials

Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a

Start date: March 15, 2021
Phase: Phase 1
Study type: Interventional

VBI-2902a and VBI-2905a are investigational vaccine candidates that use enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and are designed to induce neutralizing antibody and cell-mediated immune responses against the SARS-CoV-2 spike protein. VBI-2902a expresses the spike protein of SARS-CoV-2 Wuhan isolate (the first virus variant isolated in 2019 in Wuhan, China), while VBI-2905a expresses the spike protein of SARS-CoV-2 variant Beta (B.1.351 variant, first isolated in 2020 in South Africa). The Phase 1a portion of this study tests one- and two-dose regimens of VBI- 2902a with 5 μg S protein content and aluminum phosphate (alum) adjuvant or placebo delivered by intramuscular (IM) injection. The Phase 1b portion of the study tests a one-dose regimen of VBI-2905a with 5 μg S protein content and alum adjuvant or placebo delivered by IM injection in participants previously vaccinated with an authorized mRNA COVID-19 vaccine.