A Phase I Open-label Dose-escalation Study of Continuous Twice-daily Oral Treatment With BIBF 1120 in Japanese Patients With Advanced Solid Tumours

Boehringer Ingelheim0 sites24 target enrollmentJune 2006

ConditionsTumors

InterventionsBIBF 1120

Overview

Phase: Phase 1
Intervention: BIBF 1120
Conditions: Tumors
Sponsor: Boehringer Ingelheim
Enrollment: 24
Primary Endpoint: Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTCAE Version 3.0) associated with increasing doses of BIBF 1120
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as safe and tolerable treatment in Japanese patients with advanced solid tumours, overall safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

June 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients with a confirmed diagnosis of an advanced, non resectable and/or metastatic solid tumour (except for malignant lymphoma)
•Patients who have not responded to conventional treatment, or for whom no therapy of proven efficacy was available, or who were not amenable to established forms of treatment
•Patients recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radio-therapies (except for epilation) at least over the following periods of time:
•four weeks after chemotherapy (at least 2 weeks after receiving antimetabolite or at least 6 weeks after nitrosourea or mitomycin C)
•two weeks after receiving hormone therapy
•four weeks after receiving radiation therapy (2 weeks after radiation for symptom control)
•two weeks after receiving immunotherapy
•four weeks after surgical procedures
•Age 20 years or older
•Life expectancy of at least 3 months

Exclusion Criteria

Not provided

Arms & Interventions

BIBF 1120

Intervention: BIBF 1120

Outcomes

Primary Outcomes

Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTCAE Version 3.0) associated with increasing doses of BIBF 1120

Time Frame: up to 36 months

Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120

Time Frame: Up to 36 months

Secondary Outcomes

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours after single dose administration (AUC0-12)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the first drug administration)
Change from baseline in peripheral blood biomarkers(Baseline, day 2, day 8, day 30)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24hours after single dose administration (AUC0-24)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration (AUC0-∞)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Maximum measured concentration of the analyte in plasma following a single dose (Cmax)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Time from dosing to the maximum concentration of the analyte in plasma following a single dose (tmax)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Terminal half-life of the analyte in plasma after single dose administration (t1/2)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
maximum tolerated dose (MTD) of BIBF 1120(Up to 36 months)
Apparent clearance of the analyte in plasma after single dose extravascular administration (CL/F)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Objective tumour response according to the response evaluation criteria in solid tumours (RECIST)(Up to 36 months)
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Τime from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration after single dose administration (AUC0-tz)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
The percentage of the AUCtz-∞ that is obtained by extrapolation (%AUCtz-∞)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Mean residence time of the analyte in the body after single dose oral administration (MRTpo)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Area under the concentration-time curve of the analyte in plasma at steady state over the time interval from 0 to 24hours (AUC0-24,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Terminal rate constant in plasma at steady state (λz,ss)(Up to 36 month)
Terminal rate constant in plasma after single dose administration (λz)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration)
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Average concentration of the analyte in plasma at steady state (Cavg)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)(before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration)
Accumulation ratio (RA)(Up to 36 month)
Predose concentration of the analyte in plasma immediately before administration of the n-th dose (Cpre,n)(Day 8, 15 and day 22 after start of treatment)