BN80927 in Patients With Advanced Malignant Solid Tumors

NCT01435096 | Completed Phase 1

• 2 other identifiers: 2-55-52905-7012005-002703-16
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose determined by incidence of dose limiting toxicity.

  During cycle 1, up to 3 weeks

• Recommended dose determined by incidence of dose limiting toxicity.

  During cycle 1, up to 3 weeks

Secondary Outcomes (6)

• 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)

• Cmax

  72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)

• Area Under Curve

  72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)

• Tmax

  72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)

• T1/2

  72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)

Study Arms (1)

BN80927

EXPERIMENTAL

Drug: BN80927

Interventions

BN80927 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.

BN80927

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (3)

Centre Paul Papin

Angers, France

Location

Centre Eugene Marquis

Rennes, France

Location

Centre Rene Huguenin

Saint-Cloud, France

Location

MeSH Terms

Interventions

BN 80927

Study Officials

• Ipsen Study Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: September 15, 2011
• Study Start: November 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

FR (3)