A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

OBJECTIVES:

• Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.
• Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.
• Evaluate the effectiveness of this treatment regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

The dose of MG98 is escalated in cohorts of 1-6 patients 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.