NCT00616213

PR104 and G-CSF in Treating Patients With Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (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. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors. Secondary * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	filgrastim will be administered at a standard dose and schedule
DRUG	PR104	PR104 is administered intravenously once every 21 days
OTHER	F-18-fluoromisonidazole	F-18-fluoromisonidazole is administered intravenously prior to performance of PET scan

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-09-01
• Completion: 2009-06-01
• First posted: 2008-02-15
• Last updated: 2011-06-01

Locations

3 sites across 2 countries: United States, New Zealand