Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Study was opened to recruitment until 29-Oct-2021, however from 15-Apr-2021 no patient was recruited.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) v 1.1).
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN if no demonstrable liver metastases, or otherwise ≤5 x ULN
* Alkaline Phosphatase (ALP) \<5 x ULN
At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
Signed and dated written informed consent in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
You may not be if
Patients willing to undergo mandatory tumour biopsy at the time points specified in the protocol.
Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1 (R01-0787).
Adequate organ function defined as all of the following:
* Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L; haemoglobin ≥9.0 g/dL; platelets ≥100 x 10\^9/L without the use of haematopoietic growth factors within 4 weeks of start of study medication.
* Total bilirubin ≤1.5 x the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤3 x ULN or direct bilirubin ≤1.5 x ULN.
Osteoporosis ≥ CTCAE Grade 2
Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator.
Clareo Health | A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread
