Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
PHASE1
80 participants
INTERVENTIONAL
1999-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase I trial to study the effectiveness of BIBX 1382 in treating patients who have solid tumors.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIBX 1382
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian Dittrich, MD
Role: STUDY_CHAIR
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Innsbruck Universitaetsklinik
Innsbruck, , Austria
Kaiser Franz Josef Hospital
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Ludwig Institute for Cancer Research-Brussels Branch
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Herlev Hospital - University Hospital of Copenhagen
Herlev, , Denmark
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Leon Berard
Lyon, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinik und Strahlenklinik - Essen
Essen, , Germany
Klinikum Nurnberg
Nuremberg (Nurnberg), , Germany
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Rotterdam Cancer Institute
Rotterdam, , Netherlands
Norwegian Radium Hospital
Oslo, , Norway
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Kantonsspital - Saint Gallen
Sankt Gallen, , Switzerland
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
C.R.C. Beatson Laboratories
Glasgow, Scotland, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-16981
Identifier Type: -
Identifier Source: secondary_id
EORTC-16981
Identifier Type: -
Identifier Source: org_study_id