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NCT ID: NCT00988208 Completed - Prostate Cancer Clinical Trials

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

Mainsail
Start date: November 11, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

NCT ID: NCT00987389 Completed - Clinical trials for Microscopic Polyangiitis (MPA)

Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis

PEXIVAS
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is as effective as a standard disease regimen. The FDA-OOPD is one of the funding sources for this study.

NCT ID: NCT00987337 Completed - Hepatitis C Clinical Trials

Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects

FITNESS
Start date: November 2009
Phase: Phase 2
Study type: Interventional

The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

NCT ID: NCT00986154 Completed - Clinical trials for Venous Thromboembolism

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Start date: October 2009
Phase: Phase 3
Study type: Interventional

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

NCT ID: NCT00984282 Completed - Thyroid Neoplasms Clinical Trials

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Start date: October 15, 2009
Phase: Phase 3
Study type: Interventional

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

NCT ID: NCT00984048 Completed - Colorectal Cancer Clinical Trials

Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer

Start date: August 2009
Phase:
Study type: Observational

This is a multicenter translational study to understand therapeutic resistance in patients undergoing first-line chemotherapy (FOLFOX/Avastin, or FOLFIRI/Avastin) for metastatic colorectal cancer. Tissue samples from liver metastasis will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn monthly and stored in the tissue biobank.

NCT ID: NCT00983619 Completed - Cancer Clinical Trials

A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies

Start date: April 16, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).

NCT ID: NCT00983190 Completed - Heart Failure Clinical Trials

BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature

BeneMACs
Start date: July 2009
Phase: N/A
Study type: Interventional

Study Purpose The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent to or better than published results in the scientific literature with approved devices. Implants will be performed following the HeartMate II guidelines. Characterization of Patient Population The HeartMate II will be implanted as destination therapy in patients who are not candidates for cardiac transplantation. Study Design The study is a prospective, non-randomized, non-blinded multi-center study with historical control. The study will consist of the assignment of eligible patients to treatment with the LVAD. The first 10 patients to have the device implanted will be enrolled in the study. Study End point Patients enrolled in the study will be followed until end points defined as death, 2-year support on the HeartMate II, device removal, transplantation, or recovery. Data Collection and Follow-up All data will be entered into INTERMACS® through their web-based data entry system. All data for the BeneMACs study will be held separately from the main INTERMACS database, and used only for the purpose of the BeneMACs study. Investigator sites Cliniques Universitaires St. Luc, Avenue Hippocrates 10, 1200 Brussels, Belgium Leuven Gasthuisberg University Hospital, Herestraat 49, 3000 Leuven, Belgium

NCT ID: NCT00983060 Completed - Clinical trials for Chronic Hepatitis C Genotype-1 Relapse

Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients

Start date: September 2009
Phase: Phase 2
Study type: Interventional

This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.

NCT ID: NCT00982865 Completed - Cancer Clinical Trials

Trial of MSC1936369B in Subjects With Solid Tumors

Start date: December 31, 2007
Phase: Phase 1
Study type: Interventional

This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with MSC1936369B.