A Phase I Study of the PK, Tissue Distribution and Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen, 99mTc-MIP-1404 and 99mTc-MIP-1405, in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers
This trial is a single-blind, randomized, cross-over design. Up to six patients with
confirmed metastatic prostate adenocarcinoma; six newly diagnosed, high-risk patients with
prostate adenocarcinoma; and up to six healthy volunteers will receive 20.0 (± 3) mCi of
intravenously administered 99mTc MIP 1404 or 99mTc MIP 1405. Whole-body planar
scintigraphic images will be acquired at various times post-injection over 24 hours. A
pelvic SPECT/CT image will be acquired on the first day. Blood and urine will be collected
for pharmacokinetic measurements and metabolic analysis over 24 hours. Each patient will
receive an initial study drug administration and a second study drug administration
approximately 14 to 21 days after the first. A final follow-up visit will occur
approximately 2-3 weeks after the second study drug.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Safety of Administered dose
The safety data will be summarized for all patients receiving at least one dose of study drug. Summary tables, including change from pre dose to post dose where applicable, will be presented for the following safety endpoints: Treatment emergent adverse events Clinical Laboratory Evaluations Physical examination, vital signs, and ECGs
From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject)
No
Stanley J Goldsmith, MD
Principal Investigator
New York Presbyterian Hospital - Weill Medical College of Cornell University
United States: Food and Drug Administration
TcTx-P101
NCT01261754
December 2010
Name | Location |
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New York Presbyterian Hospital - Weill Medical College of Cornell University | New York, New York 10065 |