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

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

NCT02961491•Molecular Insight Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•Pregnant or nursing females
•Men or women of childbearing potential and unwilling to use a medically acceptable form of contraception from time of consent until 6 months following last therapeutic dose of AZEDRA
•Active CNS lesions by CT/MRI within 3 months of informed consent
•NYHA class IV heart failure, unstable angina pectoris or clinically significant cardiac arrhythmia that poses a risk of syncope or cardiac arrest
•Prior systemic radiotherapy resulting in marrow toxicity within 3 months of first AZEDRA therapeutic dose
•Prior iobenguane I 131 therapeutic exposure within 12 weeks of the first planned therapeutic dose
•Prior administration of whole-body radiation therapy within 12 weeks of the first planned therapeutic dose
•Prior external beam radiotherapy to \> 25% of bone marrow
•Prior chemotherapy or investigational compound and/or device within 30 days of the dosimetry dose
•Other active malignancy requiring additional treatment except for superficial cutaneous neoplasms
+7 more criteria

Locations (3)

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

Key Dates

Last Updated

January 30, 2019

Conditions

PheochromocytomaParaganglioma

Interventions

Ultratrace Iobenguane I131

DRUG

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

NCT04924075

Pheochromocytoma/ParagangliomaPancreatic Neuroendocrine Tumor+3 more

View study

RECRUITING

Familial Investigations of Childhood Cancer Predisposition

NCT03050268

Acute LeukemiaAdenomatous Polyposis+44 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Familial Investigations of Childhood Cancer Predisposition

Institutional Registry of Rare Diseases

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma

The Incidence and Outcomes of Metabolically Active Brown Adipose Tissue (aBAT) in Patients With Pheochromocytoma or Paraganglioma (PPGLs)