2N-13-2: A Randomized, Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma
This is an open-label, multicenter, randomized Phase 3 study of patients with Stage IIIB/IV NSCLC of adenocarcinoma histology.Primary Objective is to evaluate and compare overall survival (OS) in non-small cell lung cancer (NSCLC) patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone.Ganetespib is a novel synthetic small molecule that binds to the adenosine triphosphate (ATP) pocket in the N-terminus of Hsp90 and demonstrates significant activity for down-regulating Hsp90 client protein levels. This ability to impact a broad array of important oncogenes and cell signaling kinases is reflected in ganetespibs activity across a wide variety of tumor cell types.Patients will be randomized in a 1:1 ratio to receive either ganetespib in combination with docetaxel or docetaxel alone. The study will enroll approximately 500 patients, 12 from USC, over a planned 12-month period, and patients will be randomized into one of two treatment arms.
An Open-Label, Multicenter, Historically-Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Liver Failure (ALF)
VTI-212 is an open-label, multicenter, historically-controlled study of subjects with acute
liver failure (ALF). Approximately 40 subjects who meet the eligibility requirements of the
study will receive ELAD treatment in addition to standard of care treatment for ALF. The
outcomes of these subjects will be compared with matched historical controls drawn from
existing databases.
Subjects will undergo ELAD treatment for a minimum of 3 days (72 hours). It is recommended
ELAD treatment be continued up to 10 days (240 hours).
Following ELAD treatment, subjects will continue standard medical therapy as defined by the
institution and be followed through Study Day 28.
Subjects' diagnosis of ALF will be attributed to one of the following:
1. FHF (acute liver failure with no preexisting liver disease);
2. Primary Graft Non-Function (PNF);
3. Surgically-Induced Liver Failure (including subjects with small for size liver
transplants, living donor liver transplants, and subjects with risk of ALF following
liver cancer surgery.
Screening evaluations and assessments will be completed for subjects and reviewed against
inclusion/exclusion criteria.
Enrollment will define the time of study entry (Hour 0, Study Day 1, study baseline) and
inclusion in the ITT population. Subjects will be evaluated throughout the 28-day study
period.
If standard medical therapy, as defined by the institution and this protocol is consistent
with discharging the subject home, then the subject should be discharged. Prior to
discharge, the subject will be advised to attend all follow-up visits.
An extension of this study, VTI-212E, will provide additional ELAD survival data, as
available, through VTI-212 study termination (after the last surviving enrolled ELAD subject
completes Study Day 28). This registry protocol segment of VTI-212 extends the safety
monitoring period to 5 years to assess survival, incidence and characterization of tumor (in
particular hepatocellular tumor), incidence of liver transplant, and assess quality of life
using a standard, validated questionnaire.
Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links with Clinical Outcomes
Observational study to collect F/U imaging & clinical endpoint data from pts. who successfully completed baseline coronary IVUS (intravascular ultrasound) imaging in the dal-PLAQUE 2 (DP2) study to determine the correlation & clinical relevance of such imaging as related to coronary artery disease (CAD). Pts. who have had baseline angiography/IVUS, with or w/o baseline carotid ultrasound but NOT undergone follow-up angiography/IVUS as part of DP2 will have F/U angiogram/IVUS within 18-27 mos. of baseline imaging. Pts. who have had baseline carotid ultrasound but NOT undergone a F/U carotid ultrasound as part of DP2 will have follow-up carotid ultrasound within 18-27 mos. of baseline imaging. Main objectives is to compare: extent of atherosclerosis in coronary arteries with the extent of atherosclerosis in carotid arteries at a single point in time. Pts. who have successfully undergone baseline IVUS imaging, with or w/o baseline carotid ultrasound, in DP2 will be included. Pts., who successfully completed baseline angiography/IVUS in DP2, with or w/o baseline carotid ultrasound, will be scheduled for final F/U angiography/IVUS any time between 18-27 mos. after DP2 baseline imaging. Pts. who successfully completed baseline carotid ultrasound in DP2 will be scheduled for F/U carotid ultrasound any time between 18 -27 mos. after DP2 baseline imaging. Endpoints: death, death from coronary heart disease, resuscitated cardiac arrest, non-fatal MI, stroke, hospitalization for documented acute coronary syndrome, coronary revascularization procedure & carotid artery surgery or angioplasty. Pts. will have annual phone contact for 3 yrs. to check for the occurrence of cardiovascular & cerebrovascular clinical endpoints. Imaging parameters from this study will be combined with the imaging data from DP2 to compare coronary & carotid atherosclerosis extent at baseline & rate of progression up to 2 yrs.
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
This study is complementary to a multi-center, randomized, double-blind,parallel-group,
placebo-controlled, variable treatment duration study comparing the efficacy and safety of
BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both
immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the
setting of a SPMS clinical trial.
This study is part of a multi-center study, with the University of Michigan serving as the
central site.
Medtronic CoreValve® U.S. Expanded Use Study
The primary objective of the study is to evaluate the safety and effectiveness of the
Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme
Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a
composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic
severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled
in this study have a predicted operative mortality or serious, irreversible morbidity risk
of ≥50% at 30 days associated with surgical aortic valve replacement.
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