BN80927 in Patients With Advanced Malignant Solid Tumors

Ipsen

Status and phase

Completed

Phase 1

Conditions

Malignant Solid Tumour

Treatments

Drug: BN80927

Study type

Interventional

Funder types

Industry

Identifiers

NCT01435096

2-55-52905-701

2005-002703-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.