Celgene
Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
Conditions: Multiple Myeloma
To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with alikelihood of benefit from the pomalidomide treatment while the medication is notcommercially available
Ariad Pharmaceuticals
Expanded Access Program of Ponatinib
Conditions: Chronic Myeloid Leukemia (CML), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
This protocol will allow expanded access of ponatinib to patients ≥18 years with chronicmyeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblasticleukemia (Ph+ALL) who have failed all available treatment options.
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.
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.
Amicus Therapeutics
Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease
Conditions: Fabry Disease
This program allows physicians to request permission from Amicus Therapeutics (Amicus)for treatment access to migalastat hydrochloride (HCl) for specific adult patients withFabry disease. Treatment is open label for 6 months with renewal every 6 months.
Bolton Medical
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Conditions: Thoracic Aortic Aneurysm, Penetrating Ulcers
This study is a continuation of the pivotal trial studying the safety and efficacy of theRelay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is beingevaluated by the device-related adverse event rate of endovascular repair (via the Relaythoracic stent-graft) through 1 year. Safety is being evaluated by comparing majoradverse events through 1 year in subjects treated with the Relay thoracic stent-graft tothose who underwent surgical repair.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Conditions: Prostate Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male
The purpose of this study is to collect additional safety information on abirateroneacetate administered with prednisone to patients with metastatic castration-resistantprostate cancer (CRPC).
Genentech, Inc.
A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Conditions: Basal Cell Carcinoma
This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib(GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC(mBCC) who are otherwise without satisfactory treatment options.
Shire
Treatment Protocol of Velaglucerase Alfa for Patients With Type 1 Gaucher Disease
Conditions: Gaucher Disease, Type 1
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of theenzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB,glucocerebroside accumulates within macrophages leading to cellular engorgement,organomegaly, and organ system dysfunction. The purpose of this treatment protocol is toobserve the safety of velaglucerase alfa in patients with type 1 Gaucher disease who areeither treatment naive (newly diagnosed) or who are currently being treated with theEnzyme Replacement Therapy (ERT) imiglucerase.
Mentor Worldwide, LLC
Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Conditions: Breast Reconstruction
Mentor is undertaking a five-year prospective clinical study designed to collect safetydata associated with the implantation of its gel-filled mammary prostheses. This study isan "adjunct" study, which will encompass clinical reviews of reconstructive cases in allpatients who meet clinical and regulatory criteria for breast reconstruction withgel-filled mammary prostheses. This "adjunct" study will be accomplished under a limitedclinical protocol in which specific parameters will be required but with controlssomewhat less stringent than those normally required in Investigational Device Exemption(IDE) Trials.