Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458952
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2007-04-09
Brief Title:
Phase 1 Study of Iobenguane MIBG I 131 in Patients With Malignant PheochromocytomaParaganglioma
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase I Study Evaluating the Maximum Tolerated Dose Dosimetry Safety and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant PheochromocytomaParaganglioma
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma
Detailed Description:
This was originally designed as a phase 12 study The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug If the patients tumors absorbed the drug then the patient received one therapeutic dose In the phase 1 portion the study employed a 3 3 dose escalation design Enrollment in the phase 1 portion was to be completed once researches believed that they found the highest dose that they could give patients without causing unacceptable toxicity This dose is called the maximum tolerated dose MTD Following discussions with the Food and Drug Administration FDA that occurred during the dose escalation stage of the study the protocol was amended to conclude the trial upon the identification of the MTD The Phase 2 safety efficacy stage of the study was conducted with modifications of the primary endpoint as Protocol MIP IB12B with Special Protocol Assessment Agreement with the FDA in March 2009
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