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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003980 |
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 |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | February 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 |
European Organization for Research and Treatment of Cancer |
Study Chair: | Christian Dittrich, MD | Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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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 |
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