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.
Effects of Oxytocin on Smoking
This study is examining the effects of a hormone called oxytocin on smoking. Oxytocin is a naturally occurring hormone in the brain and throughout the body In this study, oxytocin is experimental and is in the form of a nasal spray. We hope to learn if oxytocin nasal spray will help reduce the urge to smoke.
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
BACKGROUND:
Evidence supporting a routine invasive practice paradigm for patients with stable ischemic
heart disease (SIHD) is outdated. In strategy trials conducted in the 1970s, coronary artery
bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with
high-risk anatomic features. The relevance of these studies today is speculative because
contemporary secondary prevention—aspirin, beta-blockers, statins, ACE inhibitors, and
lifestyle interventions—were used minimally if at all. Subsequent trials have compared
percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as
the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce
death or myocardial infarction (MI) compared with medical therapy in SIHD patients.
COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical
therapy in SIHD patients, found that among patients selected on the basis of coronary
anatomy after cath, an initial management strategy of coronary revascularization (PCI, PCI
or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or
death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine
cath--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be
required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had
ischemia level documented at baseline had only mild or moderate ischemia, leaving open the
question of the appropriate role of cath and revascularization among higher risk patients
with more severe ischemia. Observational data suggest that revascularization of patients
with moderate-to-severe ischemia is associated with a lower mortality than medical therapy
alone, but such data cannot establish a cause and effect relationship. In clinical practice
only about half such patients are referred for cath, indicating equipoise. Furthermore,
analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline
did not reveal a benefit from PCI. This issue cannot be resolved using available data
because all prior SIHD strategy trials enrolled patients after cath, introducing undefined
selection biases (e.g., highest risk patients not enrolled) and making translation of study
results problematic for clinicians managing patients who have not yet had cath.
A clinical trial in SIHD patients uniformly at higher risk (which could not have been
performed before COURAGE and BARI 2D results were available) is needed to inform optimal
management for such patients.
DESIGN NARRATIVE:
The study protocol is final, and was distributed to sites February 2012. Study protocol v2.0
was approved in January 2014.
PARTICIPATING COUNTRIES:
North America
- Canada
- Mexico
- USA (~150 sites)
South America
- Argentina
- Brazil
- Chile
- Peru
Asia
- China
- India
- Japan
- Singapore
- Taiwan
- Thailand
- Russian Federation
Pacifica
- Australia
- New Zealand
Europe
- Austria
- Belgium
- Denmark
- France
- Germany
- Hungary
- Italy
- Lithuania
- Macedonia
- Netherlands
- Poland
- Portugal
- Romania
- Serbia
- Spain
- Sweden
- UK
Middle East
- Israel
- Saudi Arabia
- Turkey
Project FIRE: Understanding the health effects of wildfires
Wildfire seasons are increasing in length and frequency, putting more people at risk to the effects of wildfire smoke. Project FIRE (Fire Impact REsearch) aims to investigate the acute effects of wildfires on human health. To this end, we have developed a smartphone application (app) that will be made freely available to our study participants. We will use this app to collect data on smoke exposure and health symptoms before, during, and after a wildfire. The findings from this study will help us understand how wildfires affect people’s health so that ultimately, we can better prepare for future wildfires and minimize health risks to communities.
Team-Based Connected Health (TCH) to Improve Clinical Outcomes and Access in Atopic Dermatitis
Skin diseases account for 30% of all physician office visits. In the United States, access to
dermatologists remains a significant challenge for those in underserved or rural communities.
To increase access to specialists and improve patient outcomes, we will evaluate a team-based
connected health (TCH) model that enables structured asynchronous online interactions among
patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable
effective management of chronic skin diseases via high-quality and efficient online care
between providers and patients. TCH purports to bring direct and expedient specialist care to
patients and PCPs in a location-independent and asynchronous manner.
Specifically, TCH offers several ways that patients and providers can communicate online
asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and
(3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access
dermatologists online asynchronously for consultations or to request a dermatologist to
assume care of patient's skin disease. With patient-dermatologist interactions, patients can
upload clinical images and history online and obtain asynchronous evaluation and
recommendations from dermatologists directly. Finally, PCPs have the option of managing their
patients' skin diseases online. Importantly, TCH applies efficient workflow that maximally
supports providers and fosters multi-directional, informed communication among patients,
PCPs, and dermatologists.
To evaluate the impact of TCH, we use atopic dermatitis (AD) as a disease model. AD is a
common, relapsing inflammatory skin disease affecting 32 million individuals in the U.S. AD
is characterized by intense itching and red, scaly patches. It incurs significant morbidities
and high healthcare costs. To address skin inflammation, itch, and psychosocial consequences,
PCPs and dermatologists need to adopt a team-based approach to effectively manage all aspects
of AD.
The primary goal of the proposed research is to test whether the online TCH model results in
equivalent improvements in disease severity and quality of life, provides better access to
specialist care, and is cost- saving as compared to usual in-person care in pediatric and
adult patients with AD. Specifically, we will conduct a pragmatic, cluster-randomized
controlled equivalency trial and use validated measures to compare AD disease severity,
health-related quality of life, and access to care between TCH and in-person care. We will
also compare costs of the two healthcare delivery models from a societal perspective by
conducting cost- minimization and sensitivity analyses.
This proposal evaluates a significant innovation in specialty-care delivery that will likely
result in improved patient outcomes, greater access to specialists, and cost savings. The
study findings will be highly impactful and have immense dissemination potential to the
management of many other chronic diseases.
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative
study. Subjects who sign informed consent will undergo study-specific screening assessments
within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization
will be stratified by upper arm or forearm placement based on the investigator's
determination of where the study access (SA) should be located. Subjects will be followed to
24 months post SA creation at routine study visits regardless of patency status. After 24
months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up
to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV
subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation
at routine study visits.
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