- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961491
Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
January 28, 2019 updated by: Molecular Insight Pharmaceuticals, Inc.
Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-IB12B
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).
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
November 8, 2016
First Posted (ESTIMATE)
November 11, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 28, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Pheochromocytoma
- Paraganglioma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Radiopharmaceuticals
- 3-Iodobenzylguanidine
Other Study ID Numbers
- MIP-IB12B-EAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Ultratrace Iobenguane I131
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Molecular Insight Pharmaceuticals, Inc.CompletedPheochromocytoma | ParagangliomaUnited States
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Molecular Insight Pharmaceuticals, Inc.WithdrawnNeuroblastomaUnited States, Canada
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Molecular Insight Pharmaceuticals, Inc.CompletedPheochromocytoma | Paraganglioma | Carcinoid
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Gustave Roussy, Cancer Campus, Grand ParisActive, not recruitingLow Risk Differentiated Thyroid CancerFrance
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AC Camargo Cancer CenterWithdrawnNeuroendocrine TumorsBrazil
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Molecular Insight Pharmaceuticals, Inc.CompletedNeuroblastomaUnited States
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University College, LondonCancer Research UKActive, not recruitingThyroid CancerUnited Kingdom
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National Cancer Center, KoreaUnknownThyroid NeoplasmsKorea, Republic of
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The University of Hong KongCompletedNon Toxic Multinodular Goiter | High Intensity Focused Ultrasound | RAIHong Kong