- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003980
BIBX 1382 in Treating Patients With Solid Tumors
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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Innsbruck, Austria, A-6020
- Innsbruck Universitaetsklinik
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Vienna, Austria, A-1100
- Kaiser Franz Josef Hospital
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Brussels, Belgium, B-1200
- Ludwig Institute for Cancer Research-Brussels Branch
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Herlev, Denmark, DK-2730
- Herlev Hospital - University Hospital of Copenhagen
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Lyon, France, 69373
- Centre Leon Berard
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Nantes-Saint Herblain, France, 44805
- CRLCC Nantes - Atlantique
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Toulouse, France, 31052
- Institut Claudius Regaud
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Essen, Germany, D-45122
- Universitaetsklinik und Strahlenklinik - Essen
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Nuremberg (Nurnberg), Germany, D-90419
- Klinikum Nürnberg
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Amsterdam, Netherlands, 1066 CX
- Antoni van Leeuwenhoekhuis
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Amsterdam, Netherlands, 1117 MB
- Academisch Ziekenhuis der Vrije Universiteit
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Groningen, Netherlands, 9713 EZ
- Academisch Ziekenhuis Groningen
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Nijmegen, Netherlands, NL-6252 HB
- University Medical Center Nijmegen
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Rotterdam, Netherlands, 3075 EA
- Rotterdam Cancer Institute
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Oslo, Norway, N-0310
- Norwegian Radium Hospital
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Basel, Switzerland, CH-4031
- University Hospital
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Bern, Switzerland, CH-3010
- Inselspital, Bern
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Saint Gallen, Switzerland, CH-9007
- Kantonsspital - Saint Gallen
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England
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Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
- Newcastle General Hospital
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Scotland
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Dundee, Scotland, United Kingdom, DD1 9SY
- Ninewells Hospital and Medical School
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Edinburgh, Scotland, United Kingdom, EH4 9NQ
- Western General Hospital
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Glasgow, Scotland, United Kingdom, G61 1BD
- C.R.C. Beatson Laboratories
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Christian Dittrich, MD, Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-16981
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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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
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University of Texas Southwestern Medical CenterRecruitingUnspecified Adult Solid Tumor, Protocol SpecificUnited States
Clinical Trials on BIBX 1382
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Boehringer IngelheimCompleted