A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors
- Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF)
in patients with solid tumors.
- Characterize the safety of this regimen in these patients.
- Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.
- Evaluate the rate of hypoxia in various solid tumors using F-MISO PET
(18F-fluoromisonidazole positron emission tomography) imaging.
- Assess for antitumor toxicity in these patients.
- Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter, dose-escalation study of PR-104.
Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to
assess tumor hypoxia.
Patients undergo blood sample collection periodically during course 1. Samples are analyzed
for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia.
After completion of study treatment, patients are followed at 30 days.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of PR-104
3 weeks (cycle 1)
United States: Food and Drug Administration
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea||Scottsdale, Arizona 85260|
|South Texas Accelerated Research Therapeutics||San Antonio, Texas 78229|