Malignant Solid TumourPhase 1NCT01435096
BN80927 in Patients With Advanced Malignant Solid Tumors
A Phase 1 study testing BN80927 in people with Malignant Solid Tumour, run by Ipsen at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumour
- What is being tested?
- BN80927
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2004to Oct 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Paul Papin
Angers
Centre Eugene Marquis
Rennes
Centre Rene Huguenin
Saint-Cloud
About this study
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
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
- Being tested
- BN80927
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BN80927Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| BN80927 | Experimental | Not described Receives: Drug: BN80927 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose determined by incidence of dose limiting toxicity.
Measured: During cycle 1, up to 3 weeks
Recommended dose determined by incidence of dose limiting toxicity.
Measured: During cycle 1, up to 3 weeks
Secondary outcomes (6)
Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
Measured: Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks)
Cmax
Measured: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Area Under Curve
Measured: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Tmax
Measured: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
T1/2
Measured: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Number of adverse events
Measured: Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startNov 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435096
- Sponsor's protocol ID
- 2-55-52905-701
- Other IDs
- 2005-002703-16, 2005
- Status last verified
- Feb 2020
- First submitted
- 24 Aug 2011
- Last updated
- 3 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01435096
- Acronym / sponsor ID
- 2-55-52905-701
- Conditions
- Malignant Solid Tumour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BN80927 | Experimental | Drug: BN80927 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BN80927Administered 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. | Drug | BN80927 |
Primary outcome
Maximum tolerated dose determined by incidence of dose limiting toxicity.
Time frame: During cycle 1, up to 3 weeks
Recommended dose determined by incidence of dose limiting toxicity.
Time frame: During cycle 1, up to 3 weeks
6 secondary outcomes
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)
Cmax
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Area Under Curve
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Tmax
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
T1/2
Time frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Study Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BN80927 in people with Malignant Solid Tumour, run by Ipsen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose determined by incidence of dose limiting toxicity. (time frame: During cycle 1, up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.