NCT00003979

CHS 828 in Treating Patients With Solid Tumors

Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• 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 CHS 828 in treating patients who have solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. * Determine a safe dose of this regimen for phase II evaluation. * Determine the pharmacokinetic profile of this regimen in these patients. * Determine any antitumor activity in these patients. OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for up to 4 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	CHS 828

Timeline

• Start date: 1999-04-01
• First posted: 2003-01-27
• Last updated: 2012-07-11

Locations

28 sites across 9 countries: Austria, Belgium, Denmark, France, Germany, Netherlands, Norway, Switzerland, United Kingdom