Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00874614
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2009-04-01
Brief Title:
A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant RelapsedRefractory PheochromocytomaParaganglioma
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in Patients With Malignant RelapsedRefractory PheochromocytomaParaganglioma
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT02961491
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
This clinical trial is designed to evaluate the effectiveness and collect additional safety information on AZEDRA iobenguane I 131 for the treatment of metastatic or relapsedrefractory to other treatment or unresectable pheochromocytoma or paraganglioma
The purpose of this trial is to test the use of AZEDRA as a treatment for pheochromocytoma and paraganglioma a rare disease This Phase II study will help determine primarily if using the drug reduces the amount of blood pressure medication being taken as a result of the cancer and secondarily to determine such things as the effectiveness of the study drug in treating the cancer additional safety measures and to assess if the drug helps the quality of life and use of pain medication All subjects will receive an imaging dose with scans followed by two therapeutic doses given approximately 3 months apart
The purpose of this trial is to test the use of AZEDRA as a treatment for pheochromocytoma and paraganglioma a rare disease This Phase II study will help determine primarily if using the drug reduces the amount of blood pressure medication being taken as a result of the cancer and secondarily to determine such things as the effectiveness of the study drug in treating the cancer additional safety measures and to assess if the drug helps the quality of life and use of pain medication All subjects will receive an imaging dose with scans followed by two therapeutic doses given approximately 3 months apart
Detailed Description:
AZEDRA Iobenguane I 131 is a very high-specific-activity iobenguane I 131 produced using proprietary Ultratrace platform Based on the well-characterized cellular active transport mechanism the high specific activity of allows for effective cellular uptake of radioactivity and hence greater tumor uptake
During this study the subjects will receive two 2 Therapy Doses that are given approximately three 3 months apart Prior to administration of the first Therapy Dose subjects will be given an Imaging Dose of AZEDRA and will undergo iobenguane I 131 scans to evaluate tumor uptake and to measure normal organ distribution and allow for the calculation of radiation dose to normal organs
Screening procedures for eligibility will need to be done before imaging or therapeutic doses of AZEDRA are administered
Hospitalization is required for approximately one 1 week after each of the two 2 Therapeutic Doses Frequent follow up is necessary for the first year and some of the follow up visits may be done by a visiting health care professional in the subjects homes Subjects will be followed in the treatment study for one 1 year and for an additional four 4 years in long-term follow up
During this study the subjects will receive two 2 Therapy Doses that are given approximately three 3 months apart Prior to administration of the first Therapy Dose subjects will be given an Imaging Dose of AZEDRA and will undergo iobenguane I 131 scans to evaluate tumor uptake and to measure normal organ distribution and allow for the calculation of radiation dose to normal organs
Screening procedures for eligibility will need to be done before imaging or therapeutic doses of AZEDRA are administered
Hospitalization is required for approximately one 1 week after each of the two 2 Therapeutic Doses Frequent follow up is necessary for the first year and some of the follow up visits may be done by a visiting health care professional in the subjects homes Subjects will be followed in the treatment study for one 1 year and for an additional four 4 years in long-term follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None