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Brief Title: Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Official Title: Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-IB12B
Study ID: NCT02961491
Brief Summary: The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).
Detailed Description: MIP-IB12B, the pivotal phase 2 study evaluating efficacy and safety of AZEDRA in patients with malignant relapsed/refractory PPGL, has completed its anticipated enrollment. The purpose of this sub-study, MIP-IB12B-EAP, is to provide expanded access to AZEDRA for newly enrolled subjects with iobenguane-avid metastatic and/or recurrent PPGL and to collect additional safety data.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Iowa, Iowa City, Iowa, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States