Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-IB12B

Status: Approved for marketing
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Expanded Access
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
View:

• Able and willing to provide informed consent/assent and comply with protocol requirements

• Documented diagnosis of either pheochromocytoma or paraganglioma that was confirmed by histology or other supportive data (e.g. abnormal MIBG diagnostic study or elevated tumor markers)

• Ineligible for curative surgery for PPGL

• Failed a prior therapy for PPGL or have no alternative indicated therapy available

• Have definitive tumor avidity confirmed by the AZEDRA dosimetry dose

• Life expectancy of at least 6 months per physician

Locations
United States
Iowa
University of Iowa
Iowa City
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Texas
MD Anderson Cancer Center
Houston
Authors
Daniel Pryma, Joseph Dillon, Camillo Jimenez
Related Therapeutic Areas
Sponsors
Leads: Molecular Insight Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials