Endometrial CancerPhase 2NCT01251354
Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
A Phase 2 study testing BN83495 in people with Endometrial Cancer, run by Ipsen at 9 sites in 2 countries.
Trial summary
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- BN83495
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent prior to any study related procedures.
- postmenopausal or ovariectomised female patient over 18 years of age.
- histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
- patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
- patient has at least one measurable disease site (RECIST criteria version 1.1)
Who cannot join
- patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
- patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
- patient was treated with any other investigational agent within the 3 weeks before study entry.
- patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Canada5 sites
London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 4L6
CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
Montreal, Quebec, H2L 4M1
Department of Oncology, McGill University
Montreal, Quebec, H2W 1S6
Department of Oncology, Ottawa Cancer Center
Ottawa, Ontario, K1H 8L6
Dept of Obstetrics and Gynecology, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
United States4 sites
Dept of Obstetrics and Gynecology, Medical College of Georgia
Augusta, Georgia, 30912
Division of Gynecologic Oncology, University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Crozer Chester medical Center
Upland, Pennsylvania, 19103
About this study
Official title: A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
- Conditions
- Endometrial Cancer
- Being tested
- BN83495
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BN83495Drug
1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| BN83495 | Experimental | Not described Receives: Drug: BN83495 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)
CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.
PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: 12 weeks
Secondary outcomes (6)
Number of Participants With Adverse Events
Measured: Up to 28 days after last dose
Determination of Time to Progression (TTP) in This Patient Population
Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
Measured: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Progression Free Survival (PFS) in This Patient Population
Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
Measured: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Overall Response Rate (ORR) in This Patient Population
Overall Response Rate (ORR): Defined as the sum of CR and PR.
Measured: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Duration of Response in This Patient Population
Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.
Measured: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Overall Survival in This Patient Population
Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
Measured: 2 years after the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJul 2011
Why it stopped: The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251354
- Sponsor's protocol ID
- X-52-58064-007
- Status last verified
- Jan 2019
- First submitted
- 23 Nov 2010
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.
- ClinicalTrials.gov ID
- NCT01251354
- Acronym / sponsor ID
- X-52-58064-007
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Posted 2 Sep 2015
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 the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BN83495 | Experimental | Drug: BN83495 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent prior to any study related procedures.
- postmenopausal or ovariectomised female patient over 18 years of age.
- histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
- patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
- patient has at least one measurable disease site (RECIST criteria version 1.1)
Key exclusion criteria (4 listed)
- patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
- patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
- patient was treated with any other investigational agent within the 3 weeks before study entry.
- patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.
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 |
|---|---|---|
| BN834951 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops | Drug | BN83495 |
Primary outcome
Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)
Time frame: 12 weeks
CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
6 secondary outcomes
Number of Participants With Adverse Events
Time frame: Up to 28 days after last dose
Determination of Time to Progression (TTP) in This Patient Population
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Progression Free Survival (PFS) in This Patient Population
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Overall Response Rate (ORR) in This Patient Population
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Duration of Response in This Patient Population
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Overall Survival in This Patient Population
Time frame: 2 years after the last patient enrolled
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Medical Director study director
Ipsen
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BN83495 in people with Endometrial Cancer, run by Ipsen at 9 sites in 2 countries.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1) (time frame: 12 weeks). 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 14 Jan 2019.