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.
BioMarin Pharmaceutical
Sapropterin Expanded Access Program
Conditions: Phenylketonuria
The Purpose of this study is to provide patients with hyperphenylalaninemia (HPA) due toPhenylketonuria (PKU) access to sapropterin dihydrochloride and to collect moreinformation about the safety of the drug in an expanded access program (EAP) untilcommercial product is available.
argenx
Efgartigimod Expanded Access for Generalized Myasthenia Gravis
Conditions: Generalized Myasthenia Gravis
This expanded access protocol applies to patients with gMG who are not enrolled in anongoing clinical trial. The aim of the trial is to provide patients with generalizedmyasthenia gravis (gMG), who are ineligible to participate in a clinical trial, access toefgartigimod treatment before regulatory approval.There are country-specific protocols and also individual use EAP. Recruitment for thetreatment protocol in US is now closed (ARGX-113-EAP-2101).
Kite, A Gilead Company
Axicabtagene Ciloleucel Expanded Access Study
Conditions: Relapsed/Refractory Diffuse Large B Cell Lymphoma, Relapsed/Refractory Primary Mediastinal B Cell Lymphoma, Relapsed/Refractory Transformed Follicular Lymphoma, Relapsed/Refractory High-Grade B-Cell Lymphoma
A multicenter, open-label expanded access protocol for the treatment of subjects withrelapsed/refractory large B-cell lymphoma.Subjects who received an infusion of axicabtagene ciloleucel will complete the remainderof the 15 year follow-up assessments in a separate long-term follow-up study,KT-US-982-5968
Boehringer Ingelheim
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)
Conditions: Idiopathic Pulmonary Fibrosis
To provide early access and to evaluate the safety and tolerability of nintedanib inpatients with idiopathic pulmonary fibrosis (IPF).
Oncopeptides AB
Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma
Conditions: Relapsed and/or Refractory Multiple Myeloma
To provide early treatment access and evaluate the safety of melflufen and dexamethasonein patients with triple class refractory (TCR) multiple myeloma (MM).