A Dose Escalating Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer

Inclusion criteria

• At least 18 years of age.
• Histologically confirmed diagnosis of advanced solid or haematological malignancy not amenable to standard treatment.
• Pharmacological treatment attempt justified
• Preserved major organ functions, i.e:

• B-Leukocyte count ≥ 3.0 x 109/L
• B-Neutrophil count ≥ 1.5 x 109/L
• B-Platelet count ≥ 75 x109/L
• B-Haemoglobin ≥ 100 g/L (transfusions are allowed)
• P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the "normal" (i.e. reference) range
• P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the "normal" range, ≤5 times if liver metastases have been documented
• P-Creatinine ≤ 1.5 times upper institutional limit of the "normal" range
• Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
• Signed written informed consent.

Exclusion criteria

• Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient
• Known malignancy in CNS
• Prior anti-tumour therapy within 4 weeks from enrolment (6 weeks for nitrosurea and MitC).
• Pregnancy or lactation
• Current participation in any other interventional clinical trial
• Performance status > ECOG 2 after optimization of analgesics
• Life expectancy less than 3 months
• Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
• Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.