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 3 Weeks
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of MEN-10755 in patients with
recurrent or refractory adult solid tumors. II. Determine the qualitative and quantitative
toxic effects of MEN-10755 and study the predictability, duration, intensity, onset,
reversibility, and dose relationship of the toxic effects in these patients. III. Propose a
safe dose for phase II study. IV. Assess the pharmacokinetics of MEN-10755 at different dose
levels in these patients. V. Document any possible antitumor activity of MEN-10755.
OUTLINE: This is an open label, nonrandomized study. Patients receive MEN-10755 as a single
15 minute intravenous infusion every 3 weeks, or upon recovery from toxicity. Doses will be
escalated in decreasing rates and depending on the clinical judgement of the investigator.
The MTD is the dose at which dose limiting toxicity is observed in at least 2 of 6 patients
at a given dose level. Patients will be removed from the study if cardiac toxicity, disease
progression, or renal, cardiac or pulmonary decline is present.
PROJECTED ACCRUAL: At least 5 evaluable patients will be enrolled.
Primary Purpose: Treatment
Per Dombernowsky, MD
Copenhagen County Herlev University Hospital
United States: Federal Government