NCT00003028

MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	sabarubicin

Timeline

• Start date: 1997-04-01
• First posted: 2004-06-16
• Last updated: 2012-07-02

Locations

49 sites across 14 countries: Austria, Belgium, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Portugal, Spain, Switzerland, United Kingdom