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NCT ID: NCT01949532 Completed - Clinical trials for End-stage Renal Disease

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease

Start date: January 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.

NCT ID: NCT01949324 Completed - Clinical trials for Macular Telangiectasia Type 2

A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.

NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01945775 Completed - Breast Neoplasms Clinical Trials

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

EMBRACA
Start date: October 14, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

NCT ID: NCT01945593 Completed - Hemophilia A Clinical Trials

BAX 855 Continuation

Start date: October 15, 2013
Phase: Phase 3
Study type: Interventional

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

NCT ID: NCT01945567 Completed - Parkinson's Disease Clinical Trials

Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The posterior subthalamic area holds promise as a target region for deep brain stimulation in tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide tube surgical technique, subregions of the posterior subthalamic area can be individually targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona incerta may provide improved control of movement disorder symptoms than the more commonly stimulated dorsal zona incerta.

NCT ID: NCT01944371 Completed - HIV Clinical Trials

Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study

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

The purpose of this study is to determine the safety, pharmacology and bioactivity of disulfiram in antiretroviral treated HIV-infected adults. The investigators primary hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in CD4+ T-cells in patients on suppressive antiretroviral therapy (ART).

NCT ID: NCT01943851 Completed - Neoplasms Clinical Trials

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies

Start date: May 14, 2014
Phase: Phase 2
Study type: Interventional

This is an open-label repeat dose, multicenter, 2-part study to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily (QD) orally. Part 1 of the study is a dose escalation phase to select the recommended Part 2 dose (RP2D) based on the safety, PK, and PD profiles observed after oral administration of GSK525762. Eligible subjects with select relapsed refractory hematological malignancies (acute myeloid leukemia [AML], non-Hodgkin's Lymphoma [NHL]and multiple myeloma [MM]), will be enrolled in the QD and/or BID dosing cohorts until a MTD is established. Subjects may continue treatment in the study until disease progression, unacceptable toxicity, or withdrawal of consent. . Upon determination of the MTD, twice daily (BID) dosing cohorts may be opened to collect additional safety data and evaluate the preliminary efficacy of GSK525762 administered BID. Part 2 will explore clinical activity at the MTD or RP2D; separate expansion cohorts will be planned for acute myeloid leukemia (AML), non-Hodgkin's Lymphoma (NHL, including an exploratory sub-cohort of subjects with myc and B-Cell Leukemia (BCL)2 and/or BCL6 rearrangements/overexpression [double- and triple-hit lymphoma]), and multiple myeloma (MM). This is the first study of this agent to be conducted in subjects with these relapsed and/or refractory hematological malignancies for which no standard therapies are anticipated to result in a durable remission.

NCT ID: NCT01943045 Completed - Diabetes Mellitus Clinical Trials

Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.

NCT ID: NCT01942135 Completed - Clinical trials for Metastatic Breast Cancer

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Start date: September 26, 2013
Phase: Phase 3
Study type: Interventional

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).