BN80927 in Patients With Advanced Malignant Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01435096
First received: August 24, 2011
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Malignant Solid Tumour
Drug: BN80927
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Maximum tolerated dose determined by incidence of dose limiting toxicity. [ Time Frame: During cycle 1, up to 3 weeks ] [ Designated as safety issue: No ]
  • Recommended dose determined by incidence of dose limiting toxicity. [ Time Frame: During cycle 1, up to 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Profile of Pharmacokinetics [ Time Frame: 72 hours post-dose in treatment cycle 1 and 2 ] [ Designated as safety issue: No ]
    Cmax, Area Under Curve, Tmax, T1/2

  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: November 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BN80927 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435096

Locations
France
Centre Paul Papin
Angers, France
Centre Eugene Marquis
Rennes, France
Centre Rene Huguenin
Saint-Cloud, France
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01435096     History of Changes
Other Study ID Numbers: 2-55-52905-701
Study First Received: August 24, 2011
Last Updated: September 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014