Clinical Trial: Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Study Status: Available
Recruit Status: Available
Study Type: Expanded Access

Official Title: Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-I

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 Summary: 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.
Sponsor: Molecular Insight Pharmaceuticals, Inc.

Current Primary Outcome:

Original Primary Outcome:

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Original Secondary Outcome:

Information By: Molecular Insight Pharmaceuticals, Inc.

Dates:
Date Received: November 8, 2016
Date Started:
Date Completion:
Last Updated: November 8, 2016
Last Verified: November 2016