Cook MyoSite
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)
Conditions:
This is an expanded access program (EAP) for eligible participants designed to provideaccess to autologous muscle derived cells (AMDCs). Treating physicians may submitrequests for expanded access to Cook MyoSite's investigational product by email toMYO-ExpandedAccess@CookMyoSite.com.
Vanda Pharmaceuticals
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Conditions: Gastroparesis, Diabetic Gastroparesis
Primary Objective: To treat a single patient with gastroparesis who has requestedexpanded access with tradipitant
Leonard-Meron Biosciences, Inc.
Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
Conditions: Catheter-Related Infections
This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-LokTherapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Central LineAssociated Bloodstream Infection. Mino-Lok may be made available for patients whootherwise do not qualify for the phase 3 clinical trial (NCT02901717 )
Cancer Commons
Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
Conditions: Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer, Melanoma, Non Small Cell Lung Cancer, Thyroid Cancer, Bladder Cancer, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Ovarian Cancer, HepatoCellular Carcinoma, Glioblastoma, MAPK Gene Mutation, KRAS Activating Mutation, BRAF Gene Mutation, NRAS Gene Mutation, HRAS Gene Mutation, MEK Mutation, ERK Mutation
The objective of this expanded access program is to provide ulixertinib (BVD-523) forcompassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s),including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who haveincomplete response to or have exhausted available therapies.Ulixertinib is available for treatment as monotherapy or in combination with otherclinically tolerable agent(s), conditionally approved by the drug manufacturer.
AIM ImmunoTech Inc.
Ampligen in Chronic Fatigue Syndrome
Conditions: Chronic Fatigue Syndrome
This is an open label study of Ampligen in patients with chronic fatigue syndrome.
Eyetech Pharmaceuticals
A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema
Conditions: Diabetic Macular Edema
Establish the efficacy of initial high frequency loading of intravitreal pegaptanibbi-weekly during the initial treatment period when the VEGF levels are the greatest andthen gradually extending the administration frequency to monthly as homeostasis ensuesfor the treatment of DME, as measured by best-corrected visual acuity.
Jubilant DraxImage Inc.
Expanded Access Protocol Using 131I-MIBG
Conditions: Neuroblastoma, Pheochromocytoma, Paraganglioma
Protocol JDI2007-01 is an Expanded Access Protocol with therapeutic 131I-MIBG forpatients with neuroblastoma or pheochromocytoma / paraganglioma, who otherwise do notqualify for available treatments, or where approved treatment is not commerciallyavailable.
Northwest Biotherapeutics
Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
Conditions: GBM, Glioblastoma Multiforme
The study is an open-label expanded access study for patients for whom vaccine wasmanufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screeningprocess, but who subsequently failed to meet specific enrollment criteria. Patients willreceive therapy per investigator discretion (standard of care) as well as active vaccineper the 020221 protocol administration schedule. It is estimated that approximately 99patients will enroll in this study.
Eli Lilly and Company
Master Rollover Protocol for Continued Safety Assessment of Study Drug
Conditions: Cancer
This study is for patients who have participated in a previous study and who continue toreceive benefit to have continued access to study drug and/or treatment.
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
Individual Patient Compassionate Use of Fedratinib
Conditions: Myelofibrosis
This is an expanded access program (EAP) for eligible participants designed to provideaccess to fedratinib.Expanded access is only available in markets where fedratinib is not yet approved.