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NCT ID: NCT02338245 Completed - Clinical trials for Metastatic Breast Cancer

Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab

Start date: December 29, 2014
Phase: Phase 2
Study type: Interventional

This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy.

NCT ID: NCT02336451 Completed - Clinical trials for ALK-positive Non-small Cell Lung Cancer

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

Ascend-7
Start date: April 1, 2015
Phase: Phase 2
Study type: Interventional

This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

NCT ID: NCT02336165 Completed - Glioblastoma Clinical Trials

Phase 2 Study of Durvalumab (MEDI4736) in Patients With Glioblastoma

Start date: February 26, 2015
Phase: Phase 2
Study type: Interventional

This is an ongoing Phase 2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with glioblastoma (GBM) enrolled into 5 non-comparative cohorts. Primary study objectives, which vary by cohort due to differences in subject populations, include evaluation of the clinical efficacy as measured by the overall survival (OS) rate at 12 months (Cohort A), progression-free survival (PFS) at 6 months (Cohorts B, B2, and B3), and OS at 6 months (Cohort C). For all cohorts, secondary objectives include evaluation of the safety/tolerability and clinical efficacy of study treatment, and exploratory objectives include evaluation of the neurologic function and correlative biomarkers.

NCT ID: NCT02336139 Completed - Hepatitis C Clinical Trials

A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use

SIMPLIFY
Start date: March 16, 2016
Phase: Phase 2
Study type: Interventional

To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.

NCT ID: NCT02335164 Completed - Influenza Clinical Trials

A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults

FLU003
Start date: July 2015
Phase: Phase 1
Study type: Interventional

Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant formulations administered by intramuscular injection

NCT ID: NCT02334124 Completed - Cellulitis Clinical Trials

Comparing the Intravenous Treatment of Skin Infections in Children, Home Versus Hospital

CHOICE
Start date: January 2015
Phase: N/A
Study type: Interventional

Many children every year present to the Emergency Department (ED) at The Royal Children's Hospital (RCH) with cellulitis (skin infection). If it is mild, the children can go home with oral antibiotic treatment. If it is complicated and severe, these children are admitted to hospital for intravenous (IV, through a drip) antibiotic treatment. There is a middle group with uncomplicated moderate/severe cellulitis who require IV antibiotics but who are not acutely unwell. In order to determine whether it is just as effective for children with uncomplicated moderate to severe cellulitis to receive antibiotic treatment at home (via Hospital-In-The-Home) as it is to receive antibiotic treatment in hospital, there is a need to conduct a larger study and randomly assign children to receive either HITH or hospital ward care. The primary research question to be addressed is: In children with moderate/severe uncomplicated cellulitis, is the failure rate at 2 days following the first dose of antibiotic non-inferior for children treated with IV antibiotics at home compared to the failure rate at 2 days following the first dose for children treated with IV antibiotics in hospital?

NCT ID: NCT02333331 Completed - Sarcopenia Clinical Trials

Dose Range Finding Study of Bimagrumab in Sarcopenia

Start date: December 9, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

NCT ID: NCT02329847 Completed - Clinical trials for Hematologic Neoplasms

A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies

Start date: March 11, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.

NCT ID: NCT02329496 Completed - Aortic Stenosis Clinical Trials

REPRISE Next Generation Delivery System

NGDS
Start date: December 3, 2014
Phase: N/A
Study type: Interventional

To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

NCT ID: NCT02325830 Completed - Heart Failure Clinical Trials

CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation

REDUCE FMR
Start date: March 2015
Phase: N/A
Study type: Interventional

The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.