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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
Centre Paul Papin
Angers, France
Centre Eugene Marquis
Rennes, France
Centre Rene Huguenin
Saint-Cloud, France
Maximum tolerated dose determined by incidence of dose limiting toxicity.
Time frame: During cycle 1, up to 3 weeks
Recommended dose determined by incidence of dose limiting toxicity.
Time frame: During cycle 1, up to 3 weeks
Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
Time frame: Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks)
Cmax
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Area Under Curve
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Tmax
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
T1/2
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Number of adverse events
Time frame: Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.
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