Clinical Drug Experience Knowledgebase

Criteria

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.