BI 2536 BS in Patients With Advanced Solid Tumours and Repeated Administration in Patients With Clinical Benefit

Neoplasms Clinical Trial

Official title:

An Open Phase I Single Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211872
• Other study ID #: 1216.1
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2014
• Last updated: August 7, 2014
• Start date: August 2004

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment

• Evaluable tumour deposits

• Age of 18 years or older

• Life expectancy of at least 6 months

• Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation

• Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score = 2

• And full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Exclusion Criteria:

• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial protocol

• Pregnancy or breastfeeding

• Active infectious disease

• Known brain metastases

• Second malignancy requiring therapy

• Absolute neutrophil count less than 1500/mm3

• Platelet count less than 100 000/mm3

• Bilirubin greater than 1.5 mg/dL (> 26 µmol/L, international system of units (SI) equivalent)

• Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)

• Serum creatinine greater than 1.5 mg/dL (> 132 µmol/L, SI unit equivalent)

• Sexually active women and men who are unwilling to use a medically acceptable method of contraception

• Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)

• Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial

• Patients unable to comply with the trial protocol

• Or active alcohol or drug abuse

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• BI 2536 BS, intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) for a single dose of BI 2536 BS		Up to 16 weeks	No
Primary	MTD for single doses of BI 2536 BS on 3 consecutive days		Up to 16 weeks	No
Secondary	Assessment of objective treatment response by tumour measurements	Evaluated according to the response evaluation criteria in solid tumors (RECIST)	Up to 1 year	No
Secondary	Number of patients with adverse events		Up to 1 year	No
Secondary	Maximum concentration of BI 2536 BS analyte in plasma (Cmax)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Time from dosing to maximum concentration of BI 2536 BS in plasma (tmax)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Area under the concentration-time curve of BI 2536 BS in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Percentage of the AUC0-8 that is obtained by extrapolation (%AUC0-tz)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Terminal rate constant in plasma (?z)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Terminal half-life of BI 2536 BS in plasma (t1/2)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Mean residence time of BI 2536 BS in the body after intravenous administration (MRT)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Total clearance of BI 2536 BS in the plasma after intravascular administration (CL)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Apparent volume of distribution during the terminal phase ?z following an intravascular dose (Vz)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Apparent volume of distribution at steady state following intravascular administration (Vss)		Pre-dose, up to 216 hours after drug administration	No
Secondary	Amount of BI 2536 BS that is eliminated in urine from the time point 0 to time point 24/48 (Ae0-24/48)		Pre-dose, up to 48 hours after drug administration	No
Secondary	Fraction of analyte eliminated in urine from time point 0 to time point 24/48 (fe0-24/48)		Pre-dose, up to 48 hours after drug administration	No
Secondary	Renal clearance of BI 2536 BS from the time point 0 to time point 24/48 (CLR,0-24/48)		Pre-dose, up to 48 hours afterdrug administration	No

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