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NCT ID: NCT04139317 Terminated - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%

Start date: January 22, 2020
Phase: Phase 2
Study type: Interventional

The purpose was to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

NCT ID: NCT04128696 Terminated - Clinical trials for Neoplasms, Head and Neck

Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

INDUCE-3
Start date: November 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.

NCT ID: NCT04126031 Terminated - Clinical trials for Gram-negative Bacterial Infection

Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

NOOR
Start date: January 14, 2020
Phase: Phase 2
Study type: Interventional

This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.

NCT ID: NCT04115956 Terminated - AL Amyloidosis Clinical Trials

A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis

Start date: August 6, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1/2 open label study of melphalan flufenamide (melflufen) in combination with dexamethasone for participants with Al amyloidosis following at least one prior line of therapy. Melflufen will be administered on Day 1 of each 28-day cycle in combination with dexamethasone on days 1 and 2. In both phases, treatment of each individual participant will continue for up to 8 cycles or until any stopping events occur. Approximately 46 participants will be enrolled. The study was intended to be a Phase 1/2 trial but was early terminated and never moved forward to Phase 2.

NCT ID: NCT04059406 Terminated - Clinical trials for Beta Thalassemia Intermedia

Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx)

Start date: September 24, 2020
Phase: Phase 2
Study type: Interventional

The purpose is to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of sapablursen administered subcutaneously to participants with non-transfusion dependent β-Thalassemia Intermedia.

NCT ID: NCT04000282 Terminated - Plasma Cell Myeloma Clinical Trials

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

Start date: August 19, 2019
Phase: Phase 1
Study type: Interventional

Primary Objectives: - Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B - Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM Secondary Objectives: - To characterize the safety profile of SAR442085 - To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent - To evaluate the potential immunogenicity of SAR442085 - To assess preliminary evidence of antitumor activity in the Dose Escalation Part A

NCT ID: NCT03968419 Terminated - Clinical trials for Non-small Cell Lung Cancer

This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.

CANOPY-N
Start date: November 5, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study was to evaluate the major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR of pembrolizumab as a single agent and the dynamic of the tumor microenvironment changes on treatment.

NCT ID: NCT03936595 Terminated - Clinical trials for Power Training Exercise Protocols

Recovery of Performance, Muscle Damage and Neuromuscular Fatigue Following Muscle Power Training

PoTrRec
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Muscle power is one of the most important parameters in almost every athletic action, and expresses the ability of the human muscle to produce great amounts of force with the greatest possible speed. Thus, muscle power is critical for high performance in athletic actions such as jumping, throwing, change of direction and sprinting. For enhancing their muscle power, athletes comprise several resistance training programs as part of their training. Muscle power training comprises of eccentric muscle actions, and the magnitude of these actions depend on the emphasis that is given on the concentric or eccentric action, respectively, of the muscles during the exercises. However, eccentric muscle action, especially when unaccustomed, can lead to exercise-induced muscle damage (EIMD), and deterioration of muscle performance. Despite the fact that muscle power training comprises eccentric muscle actions, and consequently can lead to muscle injury and muscle performance reduction during the following days, the recovery kinetics after acute muscle power training have not been adequately studied. However, information regarding the recovery of the muscles after a power training protocol, is critical for the correct design of a training microcycle, and the reduction of injury risk. The aim of the present study is to investigate the muscle injury provoked after acute muscle power training using three different power training exercise protocols. Additionally, we will examine the effect of these protocols on muscle performance and neuromuscular fatigue indices.

NCT ID: NCT03920254 Terminated - Clinical trials for Ulcerative Colitis (UC)

TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study

Start date: July 23, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

NCT ID: NCT03871829 Terminated - Multiple Myeloma Clinical Trials

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.