Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
- Registration Number
- NCT02211859
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BI 2536 BI 2536 single escalating dose, followed by repeated administration in patients with clinical benefit
- Primary Outcome Measures
Name Time Method Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT) up to 3 weeks
- Secondary Outcome Measures
Name Time Method Number of patients with clinically significant changes in vital signs 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 %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 Number of patients with drug-related adverse events up to 24 days after last drug administration according to common terminology criteria for adverse events (CTCAE) 3.0
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 Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose) 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 MRT (mean residence time of the analyte in the body after intravenous administration) 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