BIBX 1382 in Treating Patients With Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00003980
• Other study ID #: EORTC-16981
• Secondary ID: EORTC-16981
• Status: Suspended
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: July 10, 2012
• Start date: February 1999

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• BIBX 1382

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	Institut Jules Bordet	Brussels
Belgium	Ludwig Institute for Cancer Research-Brussels Branch	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Denmark	Herlev Hospital - University Hospital of Copenhagen	Herlev
France	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
Germany	Universitaetsklinik und Strahlenklinik - Essen	Essen
Germany	Klinikum Nurnberg	Nuremberg (Nurnberg)
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Norway	Norwegian Radium Hospital	Oslo
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Kantonsspital - Saint Gallen	Saint Gallen
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	Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Netherlands,  Norway,  Switzerland,  United Kingdom,