BN80927 in Patients With Advanced Malignant Solid Tumors

Malignant Solid Tumour Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435096
• Other study ID #: 2-55-52905-701
• Secondary ID: 2005-002703-16
• Status: Completed
• Phase: Phase 1
• Start date: November 2004
• Est. completion date: October 2007

Study information

• Verified date: February 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-human-chorionic-gonadotrophin (ß-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.

Related Conditions & MeSH terms

• Malignant Solid Tumour
• Neoplasms

Intervention

Drug:
• BN80927
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.

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Eugene Marquis	Rennes
France	Centre Rene Huguenin	Saint-Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose determined by incidence of dose limiting toxicity.		During cycle 1, up to 3 weeks
Primary	Recommended dose determined by incidence of dose limiting toxicity.		During cycle 1, up to 3 weeks
Secondary	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)
Secondary	Cmax		72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Secondary	Area Under Curve		72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Secondary	Tmax		72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Secondary	T1/2		72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Secondary	Number of adverse events		Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.