BIBX 1382 in Treating Patients With Solid Tumors

NCT00003980 | Suspended Phase 1

• 1 other identifier: EORTC-16981
• Study Type: interventional
• Target: 80
• Locations: 9 countries
• Sites: 27

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 BIBX 1382 in treating patients who have solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

BIBX 1382 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (27)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Ludwig Institute for Cancer Research-Brussels Branch

Brussels, B-1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Herlev Hospital - University Hospital of Copenhagen

Herlev, DK-2730, Denmark

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinik und Strahlenklinik - Essen

Essen, D-45122, Germany

Location

Klinikum Nurnberg

Nuremberg (Nurnberg), D-90419, Germany

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, 1117 MB, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital - Saint Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

C.R.C. Beatson Laboratories

Glasgow, Scotland, G61 1BD, United Kingdom

Location

Study Officials

• Christian Dittrich, MD

  Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 25, 2004
• Study Start: February 1, 1999
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

BE (4); DE (2); NO (1); NL (5); AU (2); CH (3); FR (5); DK (1); GB (4)