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NCT ID: NCT03850795 Active, not recruiting - Clinical trials for Prostate Cancer Metastatic

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.

NCT ID: NCT03850067 Active, not recruiting - Clinical trials for Small Cell Lung Carcinoma

A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer

Start date: March 12, 2019
Phase: Phase 1
Study type: Interventional

CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC. The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.

NCT ID: NCT03849716 Active, not recruiting - Dermatitis Atopic Clinical Trials

Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)

Start date: April 5, 2019
Phase:
Study type: Observational [Patient Registry]

Primary Objective: To explore associations between biomarkers of atopic dermatitis (AD) and: - Disease state and time course of AD, - Disease state and evolution of selected atopic comorbid conditions, - Effectiveness of specific AD treatments.

NCT ID: NCT03847428 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

EMERALD-2
Start date: April 29, 2019
Phase: Phase 3
Study type: Interventional

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

NCT ID: NCT03845166 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

STELLAR-001
Start date: March 20, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

NCT ID: NCT03844048 Active, not recruiting - Cancer Clinical Trials

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Start date: September 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.

NCT ID: NCT03843359 Active, not recruiting - Neoplasms Clinical Trials

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

Start date: March 12, 2019
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

NCT ID: NCT03842878 Active, not recruiting - LGMD2I Clinical Trials

Natural History Study of Patients With Limb-Girdle Muscular Dystrophy 2I

Start date: February 19, 2020
Phase:
Study type: Observational

Prospective, longitudinal, interventional, single-group, multicenter natural history study to better know the LGMD2I disease physiopathology. The duration of participation for each patient will be up to 24 months.

NCT ID: NCT03842813 Active, not recruiting - Diabetes Clinical Trials

Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients

EVALU8
Start date: April 9, 2019
Phase:
Study type: Observational

The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients. As routine care, each patient will be followed until 12 months after stent implantation.

NCT ID: NCT03842449 Active, not recruiting - Smoking Cessation Clinical Trials

Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women

T-CAFE
Start date: March 18, 2019
Phase: N/A
Study type: Interventional

France is the country of Europe where the prevalence of pregnant women smokers is the highest (35.9% before pregnancy and in the 3rd quarter 21.8% in 2008). In the investigator's country, among the smokers of early pregnancy with the usual care, only 30% manage to stop during pregnancy. Maternal smoking during pregnancy is a clearly identified risk factor for the course of pregnancy and the unborn child. The measurement of carbon monoxide (CO) expired in pregnancy monitoring consultation is part of the recommendations of the consensus conference "Pregnancy and Tobacco" (ANAES, October 2004) and the parliamentary report on smoking by JL Touraine and D. Jacquat (Feb 2012). However, this recommendation has not entered the current practice. The research aims to justify the clinical relevance of this recommendation by demonstrating the positive impact of expired CO measurement on the rate of discontinuation during pregnancy.