Malignant Solid Tumour
Conditions
Brief 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.
Interventions
DRUGBN80927
Administered over 30 minutes in the vein with a fixed infusion rate once every 3 weeks. Each patient could participate in a maximum of 10 continuous cycles, equivalent to 30 weeks treatment.
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose determined by incidence of dose limiting toxicity. | During cycle 1, up to 3 weeks |
| Recommended dose determined by incidence of dose limiting toxicity. | During cycle 1, up to 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Area Under Curve | 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days) |
| Tmax | 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days) |
| Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria. | Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks) |
| Number of adverse events | Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks. |
| T1/2 | 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days) |
| Cmax | 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days) |
Countries
France
Outcome results
None listed