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NCT ID: NCT03912909 Recruiting - Obesity Clinical Trials

Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans

EMPA-SNS
Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

This study is designed to investigate whether the sodium-glucose co-transporter-2 (SGLT-2) inhibitor Empagliflozin reduces sympathetic nervous system (SNS) activity in humans.

NCT ID: NCT03911505 Recruiting - Clinical trials for Pompe Disease (Late-onset)

ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD

Start date: February 13, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric subjects with Pompe disease, aged 0 to < 18 years

NCT ID: NCT03906669 Recruiting - Clinical trials for Early-stage Breast Cancer

A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.

WinPro
Start date: March 20, 2018
Phase: Phase 2
Study type: Interventional

A phase II randomised, open label study of pre-operative endocrine therapy with & without prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+) human epidermal receptor 2 negative (HER2-) breast cancer.

NCT ID: NCT03905148 Recruiting - Solid Tumor, Adult Clinical Trials

Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors

Start date: May 1, 2019
Phase: Phase 1
Study type: Interventional

This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.

NCT ID: NCT03900442 Recruiting - Advanced Cancer Clinical Trials

Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort

Start date: September 1, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized study to evaluate the PD, PK, and safety of 500 to 2000 mg/m2 PTX-100 in patients with advanced malignancies. PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles unless toxicity is observed. Dose escalation is complete and the expansion is open and actively recruiting PTCL patients.

NCT ID: NCT03899792 Recruiting - Soft Tissue Sarcoma Clinical Trials

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

LIBRETTO-121
Start date: June 13, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

NCT ID: NCT03899155 Recruiting - Cancer Clinical Trials

Pan Tumor Rollover Study

Start date: August 9, 2019
Phase: Phase 2
Study type: Interventional

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

NCT ID: NCT03897881 Recruiting - Melanoma Clinical Trials

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

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

The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.

NCT ID: NCT03888105 Recruiting - Clinical trials for B-cell Non-Hodgkin Lymphoma (NHL)

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated

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

Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups: - In patients with follicular lymphoma (FL) grade 1-3a *1,2 - In patients with diffuse large B-cell lymphoma (DLBCL) *1,2 - In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy. - In patients with marginal zone lymphoma (MZL) *1 - In patients with other B-NHL subtypes *1 Secondary objectives are: - To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by: - ORR according to the Lugano Classification and as assessed by local investigator evaluation - Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review - Progression-free survival (PFS)*3 - Overall survival (OS) - Duration of response (DOR)*3 - Disease control rate (DCR)*3 - To evaluate the safety and tolerability of odronextamab - To assess the pharmacokinetics (PK) of odronextamab - To assess the immunogenicity of odronextamab - To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) - 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy - 2 including an anti-CD20 antibody and an alkylating agent - 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

NCT ID: NCT03879759 Recruiting - Alcohol Dependence Clinical Trials

The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence

Start date: August 22, 2018
Phase: Phase 2
Study type: Interventional

The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.