Status:
COMPLETED
BN80927 in Patients With Advanced Malignant Solid Tumors
Lead Sponsor:
Ipsen
Conditions:
Malignant Solid Tumour
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01435096
Start Date
November 1 2004
End Date
October 1 2007
Last Update
March 3 2020
Active Locations (3)
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1
Centre Paul Papin
Angers, France
2
Centre Eugene Marquis
Rennes, France
3
Centre Rene Huguenin
Saint-Cloud, France