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The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BN83495 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BN83495 | Drug | 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Obstetrics and Gynecology, Medical College of Georgia | Augusta | Georgia | 30912 | United States | ||
Six patients from five centres were screened for inclusion. All six patients were enrolled and treated
Participants were recruited from United States of America and Canada from 08-Feb-2011. Terminated on 06-Jun-2011 and Study Completion was on 26-Jul-2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | BN83495 | BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BN83495 | BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint | Posted | 12 weeks |
Up to 28 days after last dose
Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BN83495 | BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural hematoma | Injury, poisoning and procedural complications | MedDra (14.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDra (14.0) | Systematic Assessment |
Study terminated due to poor enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Oncology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C520511 | irosustat |
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| 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. | 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. | 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. | 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. | 2 years after the last patient enrolled |
| Division of Gynecologic Oncology, University of Minnesota Medical Center |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Crozer Chester medical Center | Upland | Pennsylvania | 19103 | United States |
| London Health Sciences Centre, University of Western Ontario | London | Ontario | N6A 4L6 | Canada |
| Department of Oncology, Ottawa Cancer Center | Ottawa | Ontario | K1H 8L6 | Canada |
| Dept of Obstetrics and Gynecology, Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique | Montreal | Quebec | H2L 4M1 | Canada |
| Department of Oncology, McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | BN83495 | BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops |
|
| Secondary | Number of Participants With Adverse Events | All Screened Population | Posted | Number | participants | Up to 28 days after last dose |
|
|
|
| Secondary | 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. | The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint | Posted | After the last enrolled patient has been followed for at least 6 months or has progressed or died |
|
|
| Secondary | 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. | The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint | Posted | After the last enrolled patient has been followed for at least 6 months or has progressed or died |
|
|
| Secondary | Determination of Overall Response Rate (ORR) in This Patient Population | Overall Response Rate (ORR): Defined as the sum of CR and PR. | The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint | Posted | After the last enrolled patient has been followed for at least 6 months or has progressed or died |
|
|
| Secondary | 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. | The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint | Posted | After the last enrolled patient has been followed for at least 6 months or has progressed or died |
|
|
| Secondary | 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. | The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint | Posted | 2 years after the last patient enrolled |
|
|
| 2 |
| 6 |
| 6 |
| 6 |
| Colonic obstruction | Gastrointestinal disorders | MedDra (14.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra (14.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDra (14.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDra (14.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDra (14.0) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDra (14.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDra (14.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDra (14.0) | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |