NCT00349167

PR-104 in Treating Patients With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Proacta, Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.

Detailed description

OBJECTIVES: Primary * 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. Secondary * Characterize the pharmacokinetics of PR-104 and its alcohol metabolite in these patients. * Assess evidence of antitumor activity of this drug in these patients. Tertiary * 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 study. 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	PR-104
OTHER	laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-07-06
• Last updated: 2012-11-30

Locations

1 site across 1 country: United States