CompletedNCT01435096Updated Mar 3, 2020

BN80927 in Patients With Advanced Malignant Solid Tumors

A Phase 1 interventional study of BN80927 in Malignant Solid Tumour, sponsored by Ipsen. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by Ipsen · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 56
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Malignant Solid Tumour

Browse trials for

Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 56 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 56 participants (actual)

Study arms

Experimental
BN80927
Drug: BN80927

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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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.

Study locations

3 sites

Centre Paul Papin
Angers, France
Centre Eugene Marquis
Rennes, France
Centre Rene Huguenin
Saint-Cloud, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01435096
Lead sponsor: Ipsen
Responsible party: Sponsor
First posted: Sep 15, 2011
Start date: Nov 2004
Primary completion: Oct 2007
Completion: Oct 2007
Last update: Mar 3, 2020

Study contacts

Ipsen Study Director

study director · Ipsen

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Ipsen

Start the discussion