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

Pheochromocytoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT02961491
• Other study ID #: MIP-IB12B-EAP
• Status: Approved for marketing

Study information

• Verified date: January 2019
• Source: Molecular Insight Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paraganglioma
• Pheochromocytoma

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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Molecular Insight Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,