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.
HbO2 Therapeutics LLC
Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia
Conditions: Anemia Severe
HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, orreduce the need for red blood cell transfusions in anemic patientsThis is an expanded access IND protocol, and will provide treatment with HBOC-201 toseverely anemic adults for whom blood is not an option
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.
Gradalis, Inc.
Expanded Access of Vigil in Solid Tumors
Conditions: Solid Tumor, Ewing Sarcoma, Ewing's Tumor Metastatic, Ewing's Sarcoma Metastatic, Advanced Gynecological Cancers, Ovarian Cancer, Cervical Cancer, Uterine Cancer
This is an expanded access study involving an investigational product named Vigil. Vigilis considered immunotherapy. Patients who participated in another clinical trialsponsored by Gradalis, and had Vigil made from their tumor tissue removed from a standardoperation, however failed the criteria to enroll in the other clinical trial to receiveVigil are eligible to screen for this expanded access trial to receive the Vigil madefrom their cancer cells.In this study, eligible participants will receive intradermal (under the skin) injectionsof Vigil, once every 4 weeks (28 days) for 1-12 doses, depending on the number of dosesthat was made from the cancer cells and if the participant is clinically stable. Duringthe treatment portion of the study, in addition to receiving Vigil injections,participants will also have a physical exam, blood collection for routine and researchtests, and assessment of medications, adverse events, and performance status informationwill be collected. Radiological tumor assessments will be performed every 3 months fromCycle 1. Once treatment ends, participants will continue to be seen in the clinic every 3months for similar assessments until disease progression occurs. After diseaseprogression, participants will be contacted by phone 4 times a year to determine poststudy treatment and survival status information.
University of Texas, Southwestern Medical Center at Dallas
Intermediate Expanded Access Protocol CNMAu8.EAP03
Conditions: Multiple Sclerosis
This is a single-center intermediate expanded access program to provide access to theinvestigational product, CNM-Au8, up to 25 participants diagnosed with MultipleSclerosis.
Xcovery Holdings, Inc.
Expanded Access to Ensartinib for Participants With ALK+ NSCLC
Conditions: Non-Small Cell Lung Cancer, ALK Gene Rearrangement Positive
This is an open-label, multicenter, intermediate-sized expanded access treatment protocolto the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed toprovide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearrangednon-small cell lung cancer (NSCLC).
ZevraDenmark
Early Access Program With Arimoclomol in US Patients With NPC
Conditions: Niemann-Pick Disease, Type C
NPC is a rare, relentlessly progressive, neurological disease and associated with seriousmorbidity and shortened life expectancy.The purpose of this Expanded Access Program is to provide early access to arimoclomol forpatients with Niemann-Pick Type C disease who, in the opinion and the clinical judgementof the treating physician, may benefit from treatment with arimoclomol.Participants will receive treatment with arimoclomol until their doctor finds it does nothelp them anymore, they withdraw, or the study is stopped for any reason.