A Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Patients With Advanced Solid Cancers With Repeated Administrations in Patients Showing Clinical Benefit
- Patients with histologically or cytologically confirmed diagnosis of advanced, non
resectable and / or metastatic solid cancer, who have failed conventional treatment,
or for whom no therapy of proven efficacy exists, or who are not amenable to
established forms of treatment.
- Patients should have evaluable disease, or at least one measurable lesion according
to RECIST criteria version 1.1.
- Age 18 years or older.
- Life expectancy of at least 3 months in the opinion of the investigator.
- Written informed consent that is consistent with ICH-GCP guidelines and local
- Eastern Cooperative Oncology Group performance score 0, 1 or 2.
- Absolute neutrophil count more than or equal to 1,500/µL.
- Platelets more than or equal to 100,000/µL.
- Total bilirubin less than or equal to 1.5x institution ULN.
- AST and ALT less than or equal to 2.5x institution ULN (in case of hepatic primary
cancer or known liver metastases: AST and ALT less than or equal to 5x ULN).
- Creatinine less than or equal to 1.5 x institution ULN.
- Haemoglobin more than or equal to 9g/dL.
- Haemoglobin A1c less than 8% and fasting plasma glucose less than or equal to 160
mg/dL (8.9 mmol/L).
- Active infectious disease considered by the investigator to be incompatible with the
- Serious illness or concomitant non-oncological disease considered by the investigator
to be incompatible with the protocol.
- History of thrombosis within 1 year of study or if concurrent anticoagulation
required, except low-dose warfarin.
- Patients not recovered from any therapy-related toxicities from previous chemo-,
hormone-, immuno-, molecular targeted, or radiotherapies to at least CTCAE less than
or equal to Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks
prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the
patient has recovered from the acute toxicities of that therapy.
- Patients with untreated or symptomatic brain metastases. Patients with treated,
asymptomatic brain metastases are eligible if there has been no change in brain
disease status for at least 4 weeks before starting trial medication, no history of
cerebral oedema or bleeding in the past 4 weeks before starting trial medication and
must be on a stable or reducing dose of dexamethasone. Anti-epileptic therapy will be
allowed if the patient is stable on antiepileptic treatment for 4 weeks, or more,
without adjustments before starting trial medication.
- Patients who have been treated with any of the following within 4 weeks of starting
trial medication: chemotherapy, immunotherapy, radiotherapy, molecular-targeted
therapy, biological therapies (including trastuzumab), hormone therapy for breast
cancer within 2 weeks of starting trial medication (excluding LHRH agonists in
prostate cancer, or bisphosphonates), or treatment with other investigational drugs.
- Participation in another clinical trial within the past 4 weeks before start of trial
medication or concomitantly with this trial.
- Patients unable to comply with the protocol.