Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Neoplasms Clinical Trial

Official title:

An Open Phase I Repeated 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: NCT02211859
• Other study ID #: 1216.2
• 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

Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: December 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 have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment

• Evaluable tumour deposits

• Age 18 years or older

• Life expectancy of at least six months

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

• Eastern Cooperative Oncology Group (ECOG) performance score = 2

• 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 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)

• 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)

• Women and men who are sexually active and 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• BI 2536

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)		up to 3 weeks	No
Secondary	Number of patients with drug-related adverse events	according to common terminology criteria for adverse events (CTCAE) 3.0	up to 24 days after last drug administration	No
Secondary	Number of patients with abnormal laboratory findings		up to 24 days after last drug administration	No
Secondary	Change in Eastern Cooperative Oncology Group (ECOG) performance score		baseline, up to 24 days after last drug administration	No
Secondary	Number of patients with clinically significant changes in vital signs		up to 24 days after last drug administration	No
Secondary	Number of patients with objective tumor response		up to 24 days after last drug administration	No
Secondary	Cmax (maximum concentration of the analyte in plasma)		up to 264 hours after drug administration	No
Secondary	tmax (time from dosing to maximum concentration)		up to 264 hours after drug administration	No
Secondary	AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)		up to 264 hours after drug administration	No
Secondary	%AUC0-tz (the percentage of the AUC0-8 that is obtained by extrapolation)		up to 264 hours after drug administration	No
Secondary	?z (terminal rate constant in plasma)		up to 264 hours after drug administration	No
Secondary	t1/2 (terminal half-life of the analyte in plasma)		up to 264 hours after drug administration	No
Secondary	MRT (mean residence time of the analyte in the body after intravenous administration)		up to 264 hours after drug administration	No
Secondary	CL (total clearance of the analyte in the plasma after intravascular administration)		up to 264 hours after drug administration	No
Secondary	Vz (apparent volume of distribution during the terminal phase ?z following an intravascular dose)		up to 264 hours after drug administration	No
Secondary	Vss (apparent volume of distribution at steady state following intravascular administration)		up to 264 hours after drug administration	No

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