Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    azedra
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02961491
Expanded Access Status : Approved for marketing
First Posted : November 11, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.

Tracking Information
First Submitted Date November 8, 2016
First Posted Date November 11, 2016
Last Update Posted Date January 30, 2019
 
Descriptive Information
Brief Title Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
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.
Study Type Expanded Access
Intervention Drug: Ultratrace Iobenguane I131
Subjects will receive a dosimetry dose of AZEDRA and will undergo 3 whole body scans. If the scans indicate tumor avidity for AZEDRA, the subjects will receive up to 2 therapeutic doses of AZEDRA each at 500 mCi (or 8 mCi/kg, for subjects weighing 62.5 kg or less) approximately 90 days apart.
Other Names:
  • Azedra
  • MIBG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02961491
Responsible Party Molecular Insight Pharmaceuticals, Inc.
Study Sponsor Molecular Insight Pharmaceuticals, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Molecular Insight Pharmaceuticals, Inc.
Verification Date January 2019