Solid Tumor
Conditions
Interventions
investigational material(s)
Generic name etc : BI 754091
INN of investigational material : BI 754091
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigationa
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Of full age (according to local legislation) at the time of signing of the informed consent form (ICF) 2.Women of childbearing potential (WOCBP) with negative serum pregnancy test at screening and men able to father a child, who agree to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. The requirement of contraception does not apply to women of no childbearing potential but they must have an evidence of such at screening 3.Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial etc.
Exclusion criteria
Exclusion criteria: 1.Major surgery (major according to the investigators assessment) performed within 12 weeks prior to study entry or planned within 12 months after screening, e.g. hip replacement 2.Patients who must or wish to continue the intake of restricted medications (see Section 4.2.2.2) or any drug considered likely to interfere with the safe conduct of the trial 3.Previous treatment with study medications in this trial etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety exploratory MTD Number of DLT OR | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory pharmacokinetics pharmacogenomics PK including Cmax and AUC0-504 safety efficacy exploratory pharmacokinetics pharmacodynamics pharmacogenomics other DOR | — |
Countries
Asia except Japan, Japan
Outcome results
None listed