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NCT ID: NCT03866187 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection

Start date: March 28, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed subjects under nucleo(s)tide treatment.

NCT ID: NCT03864042 Active, not recruiting - Clinical trials for Advanced Solid Tumors

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Start date: January 2, 2018
Phase: Phase 1
Study type: Interventional

This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.

NCT ID: NCT03859453 Active, not recruiting - Breast Cancer Clinical Trials

Follow-up in Early and Locally Advanced Breast Cancer Patients

Start date: October 14, 2020
Phase:
Study type: Observational

A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.

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: NCT03842189 Active, not recruiting - Clinical trials for Hemolytic Disease of the Fetus and Newborn

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Start date: April 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.

NCT ID: NCT03838978 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

Calypso Knee System Clinical Study, OUS

Start date: February 8, 2019
Phase: N/A
Study type: Interventional

A study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.

NCT ID: NCT03835520 Active, not recruiting - Cancer Clinical Trials

Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

Plasma-Target
Start date: July 11, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy. Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions. With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.

NCT ID: NCT03831464 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Metformin as RenoProtector of Progressive Kidney Disease

RenoMet
Start date: November 5, 2019
Phase: Phase 3
Study type: Interventional

A multi-center, practice-oriented, repurposing, double-blinded, placebo-controlled, randomized clinical trial. The RenoMet trial is repurposing an already approved agent (Metformin , Glucophage SR ) in a new indication (renoprotection ) in a new class of patients (chronic kidney disease patients CKD 2, 3A, 3B and including patients with renal transplant for more than 3 years).

NCT ID: NCT03822468 Active, not recruiting - Breast Cancer Clinical Trials

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

AMALEE
Start date: June 11, 2019
Phase: Phase 2
Study type: Interventional

QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib. The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule. The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with a non-steroidal aromatase inhibitor (NSAI) in pre- and postmenopausal women with hormone receptor-positive (HR-positive), HER2-negative advanced breast cancer (aBC) who have not received prior therapy for advanced disease.