Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor as a Single IV Infusion Weekly X 4, Repeated Every 6 Weeks
- Determine the maximum tolerated dose (MTD) of E7070 when administered to adult patients
with solid tumors.
- Determine the qualitative and quantitative toxic effects of this drug and study the
predictability, duration, intensity, onset, reversibility and dose relationship of the
toxic effects in this patient population.
- Propose a safe dose for phase II study.
- Assess the pharmacokinetics of this drug at different dose levels in this patient
- Determine any possible antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation study.
Patients receive E7070 IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6
weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicity.
Patients are followed every 3 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Primary Purpose: Treatment
Axel R. Hanauske, MD, PhD, MBA
United States: Federal Government