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
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Christian Dittrich, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Authority:
United States: Federal Government
Study ID:
EORTC-16981
NCT ID:
NCT00003980
Start Date:
February 1999
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
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