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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013222-16 | EudraCT Number |
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Preliminary data from study NCT00994214 do not support expected inhibition of GH and IGF-1
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The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIM 23A760 | Experimental | This dose adaptive study is planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed are 1, 2, 4, 6 and 8 mg, however, the maximum starting dose will be 4 mg. The starting dose of the first cohort will be 1 mg; the first cohort will include at least five patients. After the first fifteen patients have been treated for 4 weeks, the results will be reviewed by a Data Review Committee. An extension phase (Part B) is planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIM 23A760 | Drug | BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients eligible to continue the extension phase will be administered BIM 23A760 for further 52 weekly injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale | Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied) | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) | Up to week 24 | |
| Change in the Quality of Life (QoL) Assessment | Week 24 | |
| Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A |
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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 |
|---|---|---|---|---|---|---|
| University Hospital, Internal Medicine - Oncology | Vienna | A-9010 | Austria | |||
| UZ Antwerpen |
Patients screened were 15 and not treated were 7 (2 subjects were not included due to early termination of study by sponsor and 5 subjects failed to meet inclusion criteria).
This study was terminated prematurely. Only 8 patients were treated in part A and no patients participated in part B.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIM 23A760 | This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability). BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Week 24 |
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | Up to week 26 |
| Minimum Concentration (Cmin) BIM 23A760 Plasma Levels | At 9 timepoints up to 1 week after 24th administration in week 24 |
| Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels | At 8 timepoints up to week 24 |
| Edegem |
| 2650 |
| Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ GAsthuisberg | Leuven | 3000 | Belgium |
| Fakultní nemocnice Hradec Králové | Hradec Králové | 500 05 | Czechia |
| Fakultní nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultní nemocnice Na Bulovce, Ústav radiační onkologie | Prague | 180 81 | Czechia |
| Helsinki Central University Hospital | Helsinki | FIN-00029 | Finland |
| Turku University Hospital | Turku | FIN-20521 | Finland |
| Service de Gastroentérologie | Clichy | France |
| Unité d'Oncologie Médicale | Lyon | Cedex 03 | France |
| Institut Paoli Calmette | Marseille | 13009 | France |
| Centre René Gauducheau | Nantes | 44805 | France |
| Unité de Gastro-Entérologie | Villejuif | France |
| Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsmedizin Mainz | Mainz | 55131 | Germany |
| St James's Hospital | Dublin | Ireland |
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi | Bologna | 40138 | Italy |
| Istituti Ospitalieri di Cremona | Cremona | 26100 | Italy |
| Ospedale San Martino | Genova | 16132 | Italy |
| AO Universitaria Policlinico di Modena | Modena | 41124 | Italy |
| Ospedale S.Maria della Misericordia | Perugia | 06132 | Italy |
| Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea | Roma | 00109 | Italy |
| Latvian Oncology centre of Riga Eastern Clinical University Hospital | Riga | LV-1079 | Latvia |
| Vidzemes Hospital | Valmiera | LV-4201 | Latvia |
| UMCG | Groningen | 9700 | Netherlands |
| Erasmus MC | Rotterdam | 3015 | Netherlands |
| Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach | Gliwice | 44-101 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | , 31-501 | Poland |
| Instytut im Marii Sklodowskiej Curie | Warsaw | 02-785 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 | Wroclaw, 50-367 | 50-367 | Poland |
| Altay Regional Oncology dispensary | Barnaul | 656052 | Russia |
| Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan | Kazan' | 420111 | Russia |
| Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways" | Moscow | 125367 | Russia |
| St-Petersburg State Medical University named after academician Pavlov I.P. | Saint Petersburg | 197089 | Russia |
| St-Petersburg State Institution of Public Health City Clinical Oncology dispensary | Saint Petersburg | 198255 | Russia |
| Tula Regional Oncology Dispensary | Tula | 300053 | Russia |
| Voronezh Regional Clinical Oncology Dispensary | Voronezh | 394000 | Russia |
| Narodny onkologicky ustav | Bratislava | 83310 | Slovakia |
| Martinska fakultna nemocnice | Martin | 03601 | Slovakia |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Son Dureta | Palma de Mallorca | 07014 | Spain |
| Akademiska Hospital, Dept of Oncology & Endocrinology | Uppsala | 751 85 | Sweden |
| Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center | Donetsk | 83092 | Ukraine |
| Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital | Uzhhorod | 88000 | Ukraine |
| University Hospital Aintree | Liverpool | L9 7AL | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Christie Hospital and Holt Radium Institute | Manchester | M20 4BX | United Kingdom |
| Royal Preston Hospital, Sharoe Green Lane, Lancashire | Preston | PR2 9HT | United Kingdom |
| BIM 23A760 1 mg |
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| BIM 23A760 2 mg |
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| BIM 23A760 4 mg |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BIM 23A760 | This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability). BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Diabetic status | Number | participants |
| |||||||||||||||||||||||
| Post-menopausal status | Number | participants |
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| 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 | Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale | Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied) | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | Posted | Week 24 |
|
| |||||||||||||||||||
| Secondary | Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | Posted | Up to week 24 |
|
| ||||||||||||||||||||
| Secondary | Change in the Quality of Life (QoL) Assessment | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | Posted | Week 24 |
|
| ||||||||||||||||||||
| Secondary | Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | Posted | Week 24 |
|
| ||||||||||||||||||||
| Secondary | Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | Both ITT (Intent-To-Treat) and safety populations were the same analysis group. Treatment emergent adverse events (TEAE) reported by 2 or more patients (safety population) by primary system organ class. | Posted | Number | Participants | Up to week 26 |
|
| ||||||||||||||||||
| Secondary | Minimum Concentration (Cmin) BIM 23A760 Plasma Levels | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | Posted | At 9 timepoints up to 1 week after 24th administration in week 24 |
|
| ||||||||||||||||||||
| Secondary | Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | Posted | At 8 timepoints up to week 24 |
|
|
Up to week 26
Dose received prior to AE onset.
Two serious adverse events (SAEs) 'Confusional State' and 'Nausea' were not included as they occurred during screening phase, before starting study drug.
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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 | BIM 23A760 | This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability). BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period. | 1 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mucous stools | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to peripheral vascular system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pelvic floor muscle weakness | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Due to premature termination of the study, no data was collected/analyzed and no patient participated in Part B.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Oncology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C531242 | TBR-760 |
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| Netherlands |
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| Belgium |
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| Ireland |
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| Finland |
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| Germany |
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| N/A - Not applicable |
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