Parexel
Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Conditions: Ovarian Cancer
This is an open-label, single-arm, international, multicenter Multiple Patient ExpandedAccess Program (MPEAP). The program is designed to provide treatment access to olaparibtablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian,fallopian tube or primary peritoneal cancer without other treatment options or eligiblefor an olaparib clinical trials.
Astellas Pharma Global Development, Inc.
Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
Conditions: Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
The purpose of this study is to provide expanded access to ASP2215 for subjects withFLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite completeremission (CRc) (complete remission [CR], complete remission with incomplete hematologicrecovery [CRi], complete remission with incomplete platelet recovery [CRp]) with MRDwithout access to comparable or alternative therapy.
BioMarin Pharmaceutical
A Multicenter, Multi-national Open-label Program to Provide BMN 190 to Patients Diagnosed With CLN2 Disease
Conditions: CLN2 Disease
- To provide access to BMN 190 to patients with CLN2 disease who cannot participate in a clinical trial. - To collect additional information on the safety and tolerability of BMN 190 administration in patients with CLN2 disease.
Molecular Insight Pharmaceuticals, Inc.
Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Conditions: Pheochromocytoma, Paraganglioma
The purpose of this sub-study is to provide expanded access of AZEDRA (UltratraceIobenguane I 131) and to evaluate the safety and tolerability of AZEDRA in subjects withiobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).
Eli Lilly and Company
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
Conditions: Metastatic Breast Cancer
The treating physician/investigator contacts Lilly when, based on their medical opinion,a patient meets the criteria for inclusion in the expanded access program.
Jazz Pharmaceuticals
Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
Conditions: Epilepsy
This is an observational, open-label, flexible dose study that will prospectively andlongitudinally assess the effect of Cannabidiol (CBD) therapy in patients withdrug-resistant epilepsies through a Physician Expanded Access Investigational New Drugprotocol.
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.
PTC Therapeutics
Deflazacort Expanded Access Program for Children, Adolescents and Adults With Duchenne Muscular Dystrophy
Conditions: Duchenne Muscular Dystrophy
The expanded access program will provide access to treatment with deflazacort inchildren, adolescent, and adult patients with DMD in the U.S. who are ineligible, unable,or otherwise unwilling to enroll in a clinical study examining the efficacy ofdeflazacort while a new drug application is under preparation and review. Enrollment isopen to all eligible patients.
Genentech, Inc.
An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy
Conditions: Urothelial Carcinoma
This is an open-label, multicenter, single-arm, expanded access program (EAP) designed toprovide atezolizumab access to participants with locally advanced or metastaticurothelial carcinoma that has progressed on, or is intolerant to, a platinum-containingchemotherapy regimen.
Cook Group Incorporated
Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study
Conditions: Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Juxtarenal Aneurysms
The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigationapproved by the US FDA to study the safety and effectiveness of the Zenith® FenestratedAAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.