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

Sponsor: Molecular Insight Pharmaceuticals, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02961491

Patient View

This sub-study provides expanded access to AZEDRA for patients with iobenguane-avid metastatic/recurrent PPGL, focusing on safety data collection. Eligible participants must have a confirmed PPGL diagnosis, failed prior therapy, and meet specific health criteria. Participants receive a dosimetry dose and, if tumor avidity is confirmed, up to two therapeutic doses of AZEDRA.

Patient Parameters

Program Overview

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).

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 Criteria

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
  • Karnofsky Performance Status < 60
  • Clinically significant laboratory abnormalities prior to dosing as listed in the protocol (such as blood count abnormalities, liver enzyme abnormalities, and renal dysfunction)
  • Medical history of AIDS/HIV+
  • Active chronic alcohol abuse, chronic liver disease (not including liver metastases), hepatitis A, B, or C
  • Known allergy to iobenguane that has required medical intervention
  • Receiving a medication which inhibits tumor uptake of iobenguane I 131
  • Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject

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