NCT00004076

PNU 166148 in Treating Patients With Metastatic Solid Tumors

A Phase I Study to Evaluate MAG-CPT (PNU 166148) Given as One Single Intravenous Administration Every 4 Weeks in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Glasgow · Academic / Other
• 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 PNU 166148 in treating patients who have metastatic solid tumors that have not responded to previous treatment.

Detailed description

OBJECTIVES: I. Determine the safety profile, maximum tolerated dose, and dose limiting toxicities of PNU 166148 in patients with metastatic, refractory solid tumors. II. Define a recommended dose of PNU 166148 for a Phase II study. III. Determine the pharmacokinetic profile and molecular weight distribution of PNU 166148 and the pharmacokinetic profile of free camptothecin in these patients. IV. Assess any evidence of antitumor activity in these patients treated with this regimen. OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive PNU 166148 IV over 30 minutes. Treatment repeats every 4 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PNU 166148 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3-6 patients experience dose limiting toxicity. Patients are followed for 30 days, and then monthly thereafter only for resolution of adverse events that occurred while on study and were attributable to study drug, unless another antitumor treatment is begun. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	mureletecan

Timeline

• Start date: 1999-06-01
• First posted: 2004-06-17
• Last updated: 2013-12-19

Locations

2 sites across 1 country: United Kingdom