A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Every 3 Weeks in Patients With Solid Tumors
- Evaluate the safety and tolerability of PR-104 in patients with advanced solid tumors.
- Determine the maximum tolerated dose of PR-104 in these patients.
- Characterize the pharmacokinetics of PR-104 and its alcohol metabolite in these
- Assess evidence of antitumor activity of this drug in these patients.
- Examine metabolic changes in tumors of these patients using fludeoxyglucose F 18
positron emission tomography scanning.
OUTLINE: This is a multicenter, open-label, prospective, uncontrolled, dose-escalation
Patients receive PR-104 IV over 60 minutes on day 1. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PR-104 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Blood is collected at baseline and then periodically during study treatment for
pharmacokinetic and tumor marker studies. Patients undergo fludeoxyglucose F 18 positron
emission tomography scanning before beginning study treatment and after completion of course
2 to assess metabolic activity of the tumor.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mark D. Pegram, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|