BN80927 in Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the maximum tolerated dose and the recommended dose of BN80927 in patients with advanced malignant solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Camptothecin

Criteria

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.