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NCT ID: NCT01898364 Completed - Pompe Disease Clinical Trials

Safety and Efficacy Evaluation of Repeat neoGAA Dosing in Late Onset Pompe Disease Patients.

Start date: August 19, 2013
Phase: Phase 1
Study type: Interventional

Primary Objective: To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. Secondary Objective: To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients. To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.

NCT ID: NCT01898117 Active, not recruiting - Breast Cancer Clinical Trials

Triple-B Study;Carboplatin-cyclophosphamide Versus Paclitaxel With or Without Atezolizumab as First-line Treatment in Advanced Triple Negative Breast Cancer

Triple-B
Start date: July 2013
Phase: Phase 2
Study type: Interventional

Triple negative breast cancer (TNBC) is a difficult to treat molecular subtype with a poor survival. TNBC can be divided into at least two molecular entities; BRCA-like and non-BRCA-like. In this trial we would like to investigate whether a molecular subgroup exists within TNBCs that derives a benefit from atezolizumab added to first line chemotherapy.

NCT ID: NCT01897870 Completed - Patient Compliance Clinical Trials

The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge.

HomeCoMe
Start date: November 2013
Phase: N/A
Study type: Interventional

the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.

NCT ID: NCT01897714 Terminated - Clinical trials for Relapsed and/or Relapsed-refractory Multiple Myeloma

Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients

Start date: July 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The study will explore escalating doses of melflufen in combination with dexamethasone in small groups of patients to find the maximum tolerated dose of melflufen. That dose will then be used to determine the efficacy and safety profile of melflufen in combination with dexamethasone in a larger group of patients.

NCT ID: NCT01897532 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

Start date: July 10, 2013
Phase: Phase 4
Study type: Interventional

The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.

NCT ID: NCT01897480 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Balise
Start date: August 28, 2013
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.

NCT ID: NCT01896856 Completed - Clinical trials for Previously Treated Metastatic Colorectal Cancer

Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

Start date: October 23, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).

NCT ID: NCT01896479 Active, not recruiting - Clinical trials for Medullary Thyroid Cancer

A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

EXAMINER
Start date: December 2014
Phase: Phase 4
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

NCT ID: NCT01895946 Completed - Clinical trials for Safety and Tolerability,

Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

OAK
Start date: December 2013
Phase: Phase 1
Study type: Interventional

Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

NCT ID: NCT01895673 Completed - Liver Neoplasms Clinical Trials

PET-MRI After Radiofrequency Ablation (RFA) or Microwave Ablation (MWA)

Start date: June 2013
Phase: N/A
Study type: Observational

The primary objective of this study is to evaluate the ability of PET-MRI and to detect a local site recurrence during the first year of follow-up after RFA or MWA of colorectal liver metastases (CRLM) as compared with contrast enhanced (ce) CT and PET-CT. Standard reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with histology (when available) or clinical follow-up. Secondary outcomes are the inter-observer variability, the ability to diagnose new intrahepatic lesions and in what way PET-MRI is able to influence future treatment compared to PET-CT and ceCT. The patients satisfaction concerning the PET-MRI will be examined with a questionnaire.