Clinical trial NCT01435096: BN80927 in Patients With Advanced Malignant Solid Tumors
Official title: A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Solid Tumour
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-09-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Maximum tolerated dose determined by incidence of dose limiting toxicity.
timeFrame: During cycle 1, up to 3 weeks
measure: Recommended dose determined by incidence of dose limiting toxicity.
timeFrame: During cycle 1, up to 3 weeks
Secondary outcomes:
measure: Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
timeFrame: Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks)
measure: Cmax
timeFrame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
measure: Area Under Curve
timeFrame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
measure: Tmax
timeFrame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
measure: T1/2
timeFrame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
measure: Number of adverse events
timeFrame: Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Cloud
country: France
facility: Centre Rene Huguenin
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References: