NCT01632696

Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tumor Imaging of I-124 PGN65 in Solid Tumors

Detailed description

Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give written, informed consent and meet all inclusion criteria and no exclusion criteria, and whose laboratory results are within specified limits at the screening visit, will be enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650. Study subjects will have whole body PET/CT imaging at three different timepoints with all patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to 26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity distribution will be measured.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	I-124 PGN650 for PET/CT	I-124 PGN650 for PET/CT Day 1, Day 2 and 3.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-07-03
• Last updated: 2017-07-11

Locations

1 site across 1 country: United States