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NCT ID: NCT00708292 Completed - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, With or Without Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma.

Start date: July 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.

NCT ID: NCT00708162 Completed - HIV Infection Clinical Trials

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir added to a background regimen (containing a fully-active ritonavir-boosted protease inhibitor [PI/r] and a second agent) in HIV-1 infected, antiretroviral treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of antiretroviral agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (elvitegravir arm), or raltegravir plus background regimen (raltegravir arm).

NCT ID: NCT00707980 Completed - Clinical trials for Major Depressive Disorder

Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

NCT ID: NCT00707889 Completed - Clinical trials for Advanced Colorectal Cancer

Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer

Start date: October 2008
Phase: Phase 2
Study type: Interventional

To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.

NCT ID: NCT00707707 Completed - Breast Cancer Clinical Trials

Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

Start date: September 15, 2008
Phase: Phase 1
Study type: Interventional

This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.

NCT ID: NCT00707603 Completed - Hepatitis C Clinical Trials

Chronic Hepatitis C and Insulin Resistance

Start date: May 2006
Phase: N/A
Study type: Observational

Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC

NCT ID: NCT00707317 Completed - Tuberculosis Clinical Trials

T Cell Interferon-gamma Release Assay (TIGRA) in Immunocompromised Individuals

TBNET-TIPS
Start date: June 2008
Phase: N/A
Study type: Observational

Until recently, the tuberculin skin test (TST) was the only available diagnostic assay for detection of latent infection with M. tuberculosis (LTBI). Despite the low overall incidence of symptomatic tuberculosis infection in low-prevalence countries, the potential mortality and morbidity mandate constant vigilance to identify patients at risk for reactivation. Due to systemic immunosuppression, immunocompromised patients with latent M. tuberculosis infection are at increased risk of progression to active disease. This applies to patients with various causes of immunodeficiency such as HIV-infected patients, allogeneic stem cell and solid organ transplant recipients, patients with rheumatoid arthritis and patients with chronic renal failure. Therefore, current guidelines aimed at preventing tuberculosis infection in immunocompromized individuals recommend a generalized screening for evidence of latent infection to target appropriate preventative prophylaxis. At present, tuberculosis control programs exclusively rely on the tuberculin skin test to identify a latent infection in asymptomatic individuals. Recently, novel in vitro assays termed T cell interferon-gamma release assay (TIGRA) have become available that are based on the detection of interferon-gamma (IFN-gamma) production in T cells or supernatants after stimulation with highly specific antigens of M. tuberculosis. Two TIGRA are commercially available, the ELISPOT based T.SPOT.TB and the ELISA based QuantiFERON-TB Gold test (now available as an "IN-TUBE" version). The aim of the study is a prospective comparison of the two commercially available approved TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) with the established Mendel-Mantoux skin-test in immunocompromized patients (main focus on sensitivity and specificity). The study hypotheses are as follows: 1. In immunocompromised patients, the two commercially available approved TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) have increased sensitivity and specificity as compared to the established Mendel-Mantoux skin-test. 2. Results from QuantiFERON-TB Gold In-Tube and T.SPOT.TB do not differ in immunocompromised patients.

NCT ID: NCT00707304 Completed - Clinical trials for Non Small Cell Lung Cancer

Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

FORTIS-M
Start date: November 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

NCT ID: NCT00707239 Terminated - Clinical trials for Pneumonia, Bacterial

Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs. Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

NCT ID: NCT00706771 Completed - Renal Impairment Clinical Trials

Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study

BLISS
Start date: February 2010
Phase: Phase 2
Study type: Interventional

The investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).