CHS 828 in Treating Patients With Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00003979
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 1999