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BIBX 1382 in Treating Patients With Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003980
  Purpose

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 BIBX 1382 in treating patients who have solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: BIBX 1382
Phase I

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I and Pharmacokinetics Study to Determine the Safety of BIBX 1382 in Patients With a Solid Tumor on a Continuous Daily Oral Administration Schedule and After Single Oral and Intravenous Doses

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   80
Study Start Date:   February 1999

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of oral BIBX 1382 in patients with solid tumors. II. Determine qualitative and quantitative toxicities of oral BIBX 1382 in these patients. III. Determine predictability, duration, intensity, onset, reversibility, and dose relationship of the toxicities of oral BIBX 1382 in these patients. IV. Determine safe and optimal doses of oral BIBX 1382 for a Phase II study. V. Assess the pharmacokinetics of oral BIBX 1382 in these patients. VI. Document any antitumor activity in these patients treated with oral BIBX 1382.

OUTLINE: This is a dose escalation study. Patients receive BIBX 1382 IV over 1 hour followed 7 days later by oral BIBX 1382. Beginning 3 days later, patients receive oral BIBX 1382 daily for 28 days. Courses of daily oral BIBX 1382 repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oral BIBX 1382. The maximum tolerated dose (MTD) is defined as the dose at which dose limiting toxicity occurs in at least 2 of 6 patients. Patients are followed for up to 4 weeks.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study over 18 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor not amenable to standard treatment No symptomatic brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 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 Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No active bacterial infections No nonmalignant disease that would be incompatible with study No prior alcoholism, drug addiction, or psychotic disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational or antitumor drugs

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003980

Locations
Austria
Innsbruck Universitaetsklinik    
      Innsbruck, Austria, A-6020
Kaiser Franz Josef Hospital    
      Vienna, Austria, A-1100
Belgium
Institut Jules Bordet    
      Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen    
      Edegem, Belgium, B-2650
U.Z. Gasthuisberg    
      Leuven, Belgium, B-3000
Ludwig Institute for Cancer Research-Brussels Branch    
      Brussels, Belgium, B-1200
Denmark
Herlev Hospital - University Hospital of Copenhagen    
      Herlev, Denmark, DK-2730
France
Centre Jean Perrin    
      Clermont-Ferrand, France, 63011
Centre Leon Berard    
      Lyon, France, 69373
CRLCC Nantes - Atlantique    
      Nantes-Saint Herblain, France, 44805
Institut Claudius Regaud    
      Toulouse, France, 31052
Institut Gustave Roussy    
      Villejuif, France, F-94805
Germany
Klinikum Nurnberg    
      Nuremberg (Nurnberg), Germany, D-90419
Universitaetsklinik und Strahlenklinik - Essen    
      Essen, Germany, D-45122
Netherlands
Academisch Ziekenhuis der Vrije Universiteit    
      Amsterdam, Netherlands, 1117 MB
Academisch Ziekenhuis Groningen    
      Groningen, Netherlands, 9713 EZ
Antoni van Leeuwenhoekhuis    
      Amsterdam, Netherlands, 1066 CX
Rotterdam Cancer Institute    
      Rotterdam, Netherlands, 3075 EA
University Medical Center Nijmegen    
      Nijmegen, Netherlands, NL-6252 HB
Norway
Norwegian Radium Hospital    
      Oslo, Norway, N-0310
Switzerland
Inselspital, Bern    
      Bern, Switzerland, CH-3010
Kantonsspital - Saint Gallen    
      Saint Gallen, Switzerland, CH-9007
University Hospital    
      Basel, Switzerland, CH-4031
United Kingdom, England
Newcastle General Hospital    
      Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
United Kingdom, Scotland
Western General Hospital    
      Edinburgh, Scotland, United Kingdom, EH4 9NQ
Ninewells Hospital and Medical School    
      Dundee, Scotland, United Kingdom, DD1 9SY
C.R.C. Beatson Laboratories    
      Glasgow, Scotland, United Kingdom, G61 1BD

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Christian Dittrich, MD     Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067184, EORTC-16981
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003980
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific  

ClinicalTrials.gov processed this record on September 16, 2008




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