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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01435096 |
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Date of registration:
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24/08/2011 |
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Primary sponsor: |
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Public title:
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BN80927 in Patients With Advanced Malignant Solid Tumors
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Scientific title:
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A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01435096 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Ipsen Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ipsen |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malignant Solid Tumour
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Intervention(s)
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Drug: BN80927
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Primary Outcome(s)
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Maximum tolerated dose determined by incidence of dose limiting toxicity.
[Time Frame: During cycle 1, up to 3 weeks]
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Recommended dose determined by incidence of dose limiting toxicity.
[Time Frame: During cycle 1, up to 3 weeks]
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Secondary Outcome(s)
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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.]
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Profile of Pharmacokinetics
[Time Frame: 72 hours post-dose in treatment cycle 1 and 2]
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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)]
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Secondary ID(s)
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2-55-52905-701
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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