BN80927 in Patients With Advanced Malignant Solid Tumors

Inclusion criteria

All included patients:

• Gave their written (personally signed and dated) informed consent
• had histologically or cytologically documented malignant solid tumour
• had received no more than three prior chemotherapy regimens
• had failed the standard therapy or had no option of an active standard therapy
• had an estimated survival time of greater than 3 months (according to the investigator's assessment)
• had a World Health Organisation (WHO) performance status score ≤1
• were free from other serious concurrent disease
• had adequate bone marrow function
• had adequate liver function
• had adequate renal function
• who were female and of child-bearing potential must have had a negative result in a pre-study pregnancy test β-human-chorionic-gonadotrophin (β-HCG).

Exclusion criteria

No patient included:

• was pregnant or lactating
• was unable and/or unwilling to comply fully with the protocol and the study instructions;
• presented with any concomitant condition, which could compromise the objectives of the study
• had received an investigational drug within 30 days prior to study entry or was scheduled to require concurrent treatment with an experimental drug or treatment during the study
• had received chemotherapy or hormonotherapy within 4 weeks of study entry, or had received chemotherapy with nitrosoureas or mitomycin-C within 6 weeks of study entry
• had received any extensive palliative or curative radiotherapy (no more than 35% of their active bone marrow) within 2 weeks of study entry, or had not fully recovered from such treatment
• had previously received a bone marrow transplant (BMT) or peripheral blood progenitor cells (PBPC)
• had clinical evidence of major organ failure or brain metastases.