CLINICAL TRIALS PROFILE FOR M.V.I.-12 LYOPHILIZED

All Clinical Trials for M.v.i.-12 Lyophilized

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00024492 ↗	Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer	Completed	INSYS Therapeutics Inc	Phase 1	2001-08-01	Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the investigational formulation, is a currently marketed chemotherapeutic agent. The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug, which may permit dose intensification and/or an increase in the cumulative dose that may be administered, resulting in enhanced efficacy. LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00123877 ↗	Study of GPX-100 in the Treatment of Metastatic Breast Cancer	Terminated	Gem Pharmaceuticals	Phase 2	2005-03-01	The purpose of this early Phase II multicenter trial is to determine the objective clinical response to GPX-100, an anthracycline similar to doxorubicin, in up to 40 patients with newly diagnosed metastatic breast cancer. GPX-100 is unique among anthracyclines because it is not converted to doxorubicinol during metabolism in the body. This metabolite has been shown to be a major cause of damage to the heart (cardiotoxicity) in laboratory studies. Eligible patients who are enrolled in this study will receive GPX-100 as a single agent at the beginning of as many as 8 three week long cycles of chemotherapy. Objective measurements of tumor response will be made by computed tomography (CT) scans.
NCT00240929 ↗	A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)	Completed	MedImmune LLC	Phase 2	2002-09-01	A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
NCT00378287 ↗	A Study to Monitor Intragastric pH in Patients Taking Rabeprazole vs. Patients Taking Pantoprazole	Completed	Janssen-Ortho Inc., Canada	Phase 1	2005-10-01	The purpose of the study is to demonstrate in patients that oral rabeprazole produces equivalent acid suppression to intravenous pantoprazole on Day 1 of drug administration.
NCT00418340 ↗	Manipulation of Visceral Sensitivity and Immune System in IBS	Unknown status	London North West Healthcare NHS Trust	Phase 4	2007-12-01	Irritable bowel syndrome (IBS) is a common condition. At least 20% of the population suffer from IBS. The symptoms of abdominal pain, diarrhoea, constipation, bloating and difficulty with bowel motions are often disabling. Many of those affected are young and report a poor quality of life (QOL) to a degree that is similar to gut inflammatory conditions like ulcerative colitis and Crohn's disease. Yet the impact of IBS on patients' lives is often underestimated. This is probably because unlike inflammatory bowel disease, in which the bowel is inflammed and bleeds, the bowel in IBS looks normal. Instead the problem is of abnormal functioning of the gut the cause of which is unknown. Currently therapy for IBS is limited and until recently therapy has focused on treating the symptoms to improve QOL primarily because the underlying mechanism of IBS is poorly understood. However as more processes are being implicated in IBS e.g. visceral hypersensitivity (excessive response to sensory stimuli within the gut), infection, immune activation, dysmotility and abnormal gut fermentation , the potential for new therapies looks promising. The evidence that gut bacteria play a role in inducing IBS symptoms is due to observations of an improvement of IBS symptoms with probiotic therapy (bacterial supplements) and antibiotic therapy. Patients with IBS are hypersensitive to colorectal distension compared with healthy controls. Studies carried out in our unit have shown that visceral pain thresholds in response to stress are lower in patients with IBS compared with healthy volunteers. This hypersensitivity is apparent in response to both a physical and chemical stimulus but the triggers to visceral hypersensitivity remain largely unknown. Animal models suggest roles for both host immune response and intestinal bacteria in the induction of visceral hypersensitivity. This proposal will focus on further exploration of the mechanisms underlying visceral hypersensitivity to direct future targeting of therapy. Previous independent studies showed that (a) bacteria reduce visceral hypersensitivity, (b)probiotic therapy can alter gut immune response and (c) gut sensation is affected by the type of immune cells in the gut. Our research proposal will investigate the relationship between gut bacteria, the immune system and the sensory gut nerves in order to understand how IBS symptoms are generated. This understanding will be the critical for effective future drug treatment.

Clinical Trial Conditions for M.v.i.-12 Lyophilized

Condition Name

Condition Name for M.v.i.-12 Lyophilized
Intervention	Trials
Healthy	10
Aggressive Periodontitis	2
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity	2
Stage II Squamous Cell Carcinoma of the Oropharynx	2

Condition MeSH

Condition MeSH for M.v.i.-12 Lyophilized
Intervention	Trials
Ulcer	6
Syndrome	5
Infections	4
Clostridium Infections	4

Clinical Trial Locations for M.v.i.-12 Lyophilized

Trials by Country

Trials by Country for M.v.i.-12 Lyophilized
Location	Trials
United States	111
Germany	8
Italy	8
China	6
Canada	5

Trials by US State

Trials by US State for M.v.i.-12 Lyophilized
Location	Trials
Texas	10
Ohio	8
Massachusetts	7
California	7
Georgia	6

Clinical Trial Progress for M.v.i.-12 Lyophilized

Clinical Trial Phase

Clinical Trial Phase for M.v.i.-12 Lyophilized
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	10
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for M.v.i.-12 Lyophilized
Clinical Trial Phase	Trials
Completed	47
Not yet recruiting	14
Recruiting	10

Clinical Trial Sponsors for M.v.i.-12 Lyophilized

Sponsor Name

Sponsor Name for M.v.i.-12 Lyophilized
Sponsor	Trials
The University of Texas Health Science Center, Houston	6
Ohio State University Comprehensive Cancer Center	4
GlaxoSmithKline	3

Sponsor Type

Sponsor Type for M.v.i.-12 Lyophilized
Sponsor	Trials
Other	85
Industry	42
NIH	1