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

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

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

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: BI 2536

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 2536; single escalating dose, followed by repeated administration in patients with clinical benefit	Drug: BI 2536

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of patients with abnormal laboratory findings		up to 24 days after last drug administration
Change in Eastern Cooperative Oncology Group (ECOG) performance score		baseline, up to 24 days after last drug administration
Number of patients with clinically significant changes in vital signs		up to 24 days after last drug administration
Number of patients with objective tumor response		up to 24 days after last drug administration
Cmax (maximum concentration of the analyte in plasma)		up to 264 hours after drug administration
tmax (time from dosing to maximum concentration)		up to 264 hours after drug administration
AUC0-∞ (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
%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)		up to 264 hours after drug administration
λz (terminal rate constant in plasma)		up to 264 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)		up to 264 hours after drug administration
MRT (mean residence time of the analyte in the body after intravenous administration)		up to 264 hours after drug administration
CL (total clearance of the analyte in the plasma after intravascular administration)		up to 264 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)		up to 264 hours after drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)		up to 264 hours after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimated): August 8, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1216.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR