CHS 828 in Treating Patients With Solid Tumors

July 10, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Innsbruck Universitaetsklinik
      • Vienna, Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Brussels, Belgium, B-1000
        • Institut Jules Bordet
      • Brussels, Belgium, B-1200
        • Ludwig Institute for Cancer Research
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Copenhagen, Denmark, DK-2730
        • Herlev Hospital - University Hospital of Copenhagen
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Essen, Germany, D-45122
        • Universitaetsklinik und Strahlenklinik - Essen
      • Nuremberg, Germany, 90340
        • Klinikum Nuernberg - Klinikum Nord
  • Netherlands
      • Amsterdam, Netherlands, 1001HV
        • Vrije Universiteit Medisch Centrum
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Groningen, Netherlands, 9700 RB
        • Academisch Ziekenhuis Groningen
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3075 EA
        • Erasmus Medical Center
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
  • United Kingdom
    • England
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, Scotland, United Kingdom, G61 1BD
        • C.R.C. Beatson Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor not amenable to standard therapy
  • No symptomatic brain or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases)

Renal:

  • Creatinine no greater than 1.4 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active bacterial infection
  • No other nonmalignant disease
  • No alcoholism, drug addiction, or psychiatric disorders
  • Able to take oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
  • No concurrent radiotherapy (except palliative radiotherapy)

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drugs
  • No other concurrent antitumor drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Thomas Cerny, MD, Cantonal Hospital of St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16985

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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