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.

Clinical Trial Conditions for M.V.I.-12 LYOPHILIZED

Condition Name

Condition Name for M.V.I.-12 LYOPHILIZED
Intervention	Trials
Healthy	10
Stage IVB Squamous Cell Carcinoma of the Oropharynx	2
Diabetes Mellitus, Type 2	2
Acute Lymphoblastic Leukemia	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
Italy	8
Germany	8
China	6
Spain	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