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NCT ID: NCT03911869 Terminated - Brain Metastases Clinical Trials

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

POLARIS
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.

NCT ID: NCT03897062 Terminated - Insomnia Clinical Trials

Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

Start date: August 26, 2019
Phase: Phase 2
Study type: Interventional

Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse. This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.

NCT ID: NCT03890120 Terminated - Clinical trials for Primary Sclerosing Cholangitis

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

PRIMIS
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

NCT ID: NCT03880474 Terminated - Influenza Clinical Trials

Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults

Start date: March 18, 2019
Phase: Phase 2
Study type: Interventional

A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults aged 18 years and over. To assess the effect of MVA-NP+M1 on the reduction of laboratory confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV) in adults

NCT ID: NCT03871231 Terminated - Clinical trials for Ventricular Tachycardia

Unpinning Termination Therapy for VT/VF

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is hypothesized to be effective in stopping these dangerous heart rhythms at lower voltages and energy than current defibrillators. Consequently, UPT may improve survival, reduce patient pain from shocks, and lead to longer lasting and smaller implantable defibrillators.

NCT ID: NCT03864328 Terminated - Chronic Cough Clinical Trials

A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF

SCENIC
Start date: March 29, 2019
Phase: Phase 2
Study type: Interventional

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough. Cough in IPF is both a presenting and a complicating clinical feature, which affects approximately three quarters of IPF cases. It is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy. Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b study for the treatment of persistent cough in patients with IPF.

NCT ID: NCT03858972 Terminated - Breast Cancer Clinical Trials

Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

CONTESSA 2
Start date: February 5, 2019
Phase: Phase 2
Study type: Interventional

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane. The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). 152 patients were enrolled.

NCT ID: NCT03856099 Terminated - Clinical trials for Recurrent Glioblastoma

TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab

Start date: November 13, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.

NCT ID: NCT03850535 Terminated - Clinical trials for Acute Myeloid Leukemia

A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

Start date: March 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).

NCT ID: NCT03845257 Terminated - Clinical trials for Obstructive Lung Diseases

Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma

Start date: February 14, 2019
Phase:
Study type: Observational

Scientific research focuses on "eosinophilic inflammation" as it seems to guide the therapeutic regimen in patients with asthma and COPD. The primary objective of this prospective trial is to evaluate which parameter(s) best reflects eosinophilic inflammation by correlating tissue eosinophils (endobronchial biopsy, protected specimen brush sampling) with FeNO, peripheral blood eosinophils, and eosinophils in the bronchoalveolar lavage of patients with obstructive pulmonary disease.