CHS 828 in Treating Patients With Solid Tumors

Phase 1

Withdrawn

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003979
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Study Timeline

• Study Start: 1999-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (28)

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Ludwig Institute for Cancer Research; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Herlev Hospital - University Hospital of Copenhagen; 🇩🇰 Copenhagen, Denmark

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Leon Berard; 🇫🇷 Lyon, France

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