BN80927 in Patients With Advanced Malignant Solid Tumors

NCT ID: NCT01435096

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2007-10-31

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.

Conditions

Malignant Solid Tumour

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BN80927

Group Type: EXPERIMENTAL

BN80927

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Study Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Centre Paul Papin

Angers, , France

Centre Eugene Marquis

Rennes, , France

Centre Rene Huguenin

Saint-Cloud, , France

Countries

France

Other Identifiers

2005-002703-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2-55-52905-701

Identifier Type: -

Identifier Source: org_study_id