Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00458952
First received: April 9, 2007
Last updated: June 13, 2016
Last verified: June 2016
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pheochromocytoma
Paraganglioma
Intervention: Drug: Ultratrace Iobenguane (MIBG) I 131

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in the trial at 3 US sites. 21 patients received Ultratrace Iobenguane I 131 while 3 patients failed to meet all inclusion/exclusion criteria and were therefore not dosed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Planned Doses: 6, 7, 8 & 9 mCi/kg. Dose reductions in 7, 8 & 9 mCi/kg cohorts were made so total activity administered to pts would not greatly exceed allowed total activity of 525, 600, & 675 mCi for these groups, respectively. Thus, pts were subsequently analyzed in 2 groups of ≤500 mCi and >500mCi, consisting of 7 & 14 patients, respectively.

Reporting Groups
  Description
=< 500 mCi Ultratrace Iobenguane I 131 7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
>500 mCi 14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131

Participant Flow:   Overall Study
    =< 500 mCi Ultratrace Iobenguane I 131     >500 mCi  
STARTED     7     14  
COMPLETED     5     9  
NOT COMPLETED     2     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
=< 500 mCi Ultratrace Iobenguane I 131 7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
>500 mCi 14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
Total Total of all reporting groups

Baseline Measures
    =< 500 mCi Ultratrace Iobenguane I 131     >500 mCi     Total  
Number of Participants  
[units: participants]
  7     14     21  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     12     18  
>=65 years     1     2     3  
Age  
[units: years]
Mean (Standard Deviation)
  46.4  (15.99)     52.4  (11.41)     50.4  (13.02)  
Gender  
[units: participants]
     
Female     2     3     5  
Male     5     11     16  
Region of Enrollment  
[units: participants]
     
United States     7     14     21  



  Outcome Measures

1.  Primary:   MTD of Ultratrace Iobenguane I 131   [ Time Frame: 6 weeks post therapy dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Science Communications
Organization: Progenics Pharmaceuticals, Inc.
phone: 914 784-1825
e-mail: vdipippo@progenics.com



Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00458952     History of Changes
Other Study ID Numbers: MIP-IB12
Study First Received: April 9, 2007
Results First Received: December 15, 2015
Last Updated: June 13, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada