- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435096
BN80927 in Patients With Advanced Malignant Solid Tumors
February 28, 2020 updated by: Ipsen
A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Angers, France
- Centre Paul Papin
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Rennes, France
- Centre Eugene Marquis
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Saint-Cloud, France
- Centre René Huguenin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BN80927
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose determined by incidence of dose limiting toxicity.
Time Frame: During cycle 1, up to 3 weeks
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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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During cycle 1, up to 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks)
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Cmax
Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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Area Under Curve
Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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Tmax
Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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T1/2
Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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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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Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
August 24, 2011
First Submitted That Met QC Criteria
September 13, 2011
First Posted (Estimate)
September 15, 2011
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
February 28, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-55-52905-701
- 2005-002703-16 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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