Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every Week for 3 Consecutive Weeks, Followed by One Week's Rest
OBJECTIVES: I. Determine the maximum tolerated dose of MEN-10755 in patients with solid
tumors. II. 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. III. Propose a safe dose for phase II study. IV.
Study the pharmacokinetics of this drug at different dose levels in this patient population.
V. Document any possible antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation study. Patients receive MEN-10755 IV over 15 minutes on
days 1, 8, and 15. Treatment continues every 4 weeks, or upon recovery of toxicity,
whichever comes later. Treatment continues for at least 2 courses in the absence of
unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating
doses of MEN-10755 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 for at least 3 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Primary Purpose: Treatment
Emma Geertruida Elisabeth De Vries, MD, PhD
University Medical Centre Groningen
United States: Federal Government