Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

NCT01018953 | Terminated Phase 2 Results

• 2 other identifiers: 8-55-52060-0042009-013222-16
• Study Type: interventional
• Target: 8
• Locations: 18 countries
• Sites: 54

Brief Summary

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.

Conditions

Carcinoid Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

  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

Study Arms (1)

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).

Drug: BIM 23A760

Interventions

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.

BIM 23A760

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week.
• The patient has elevated 5-Hydroxyindoleacetic acid (above upper limit normal).
• The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis.

You may not qualify if:

• The patient has undergone surgery related to a neuroendocrine tumour (NET) within 4 weeks prior to study entry or has surgery planned during the study.
• The patient has received short acting somatostatin analogues (SSAs) within 2 weeks before study entry or has received short acting SSAs for more than 3 months.
• The patient has received a radiolabelled SSA at any time before study entry.
• The patient has received long acting SSAs under certain circumstances.
• The patient has previously received any specific anti tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months.
• The patient has signs or symptoms of cardiac insufficiency.
• The patient has an ejection fraction \<40% and/or clinically severe cardiac valvular regurgitation.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (54)

University Hospital, Internal Medicine - Oncology

Vienna, A-9010, Austria

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ GAsthuisberg

Leuven, 3000, Belgium

Location

Fakultní nemocnice Hradec Králové

Hradec Králové, 500 05, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultní nemocnice Na Bulovce, Ústav radiační onkologie

Prague, 180 81, Czechia

Location

Helsinki Central University Hospital

Helsinki, FIN-00029, Finland

Location

Turku University Hospital

Turku, FIN-20521, Finland

Location

Service de Gastroentérologie

Clichy, France

Location

Unité d'Oncologie Médicale

Lyon, Cedex 03, France

Location

Institut Paoli Calmette

Marseille, 13009, France

Location

Centre René Gauducheau

Nantes, 44805, France

Location

Unité de Gastro-Entérologie

Villejuif, France

Location

Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

St James's Hospital

Dublin, Ireland

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

Istituti Ospitalieri di Cremona

Cremona, 26100, Italy

Location

Ospedale San Martino

Genova, 16132, Italy

Location

AO Universitaria Policlinico di Modena

Modena, 41124, Italy

Location

Ospedale S.Maria della Misericordia

Perugia, 06132, Italy

Location

Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea

Roma, 00109, Italy

Location

Latvian Oncology centre of Riga Eastern Clinical University Hospital

Riga, LV-1079, Latvia

Location

Vidzemes Hospital

Valmiera, LV-4201, Latvia

Location

UMCG

Groningen, 9700, Netherlands

Location

Erasmus MC

Rotterdam, 3015, Netherlands

Location

Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach

Gliwice, 44-101, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, , 31-501, Poland

Location

Instytut im Marii Sklodowskiej Curie

Warsaw, 02-785, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1

Wroclaw, 50-367, 50-367, Poland

Location

Altay Regional Oncology dispensary

Barnaul, 656052, Russia

Location

Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan

Kazan', 420111, Russia

Location

Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"

Moscow, 125367, Russia

Location

St-Petersburg State Medical University named after academician Pavlov I.P.

Saint Petersburg, 197089, Russia

Location

St-Petersburg State Institution of Public Health City Clinical Oncology dispensary

Saint Petersburg, 198255, Russia

Location

Tula Regional Oncology Dispensary

Tula, 300053, Russia

Location

Voronezh Regional Clinical Oncology Dispensary

Voronezh, 394000, Russia

Location

Narodny onkologicky ustav

Bratislava, 83310, Slovakia

Location

Martinska fakultna nemocnice

Martin, 03601, Slovakia

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Son Dureta

Palma de Mallorca, 07014, Spain

Location

Akademiska Hospital, Dept of Oncology & Endocrinology

Uppsala, 751 85, Sweden

Location

Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center

Donetsk, 83092, Ukraine

Location

Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital

Uzhhorod, 88000, Ukraine

Location

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Christie Hospital and Holt Radium Institute

Manchester, M20 4BX, United Kingdom

Location

Royal Preston Hospital, Sharoe Green Lane, Lancashire

Preston, PR2 9HT, United Kingdom

Location

MeSH Terms

Conditions

Serotonin Syndrome

Interventions

TBR-760

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Limitations and Caveats

Due to premature termination of the study, no data was collected/analyzed and no patient participated in Part B.

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: November 20, 2020
• Results First Posted: September 7, 2015

Record last verified: 2020-11

Locations

FR (5); ES (3); RU (7); CZ (3); AU (1); FI (2); DE (3); SE (1); BE (3); UA (2); IT (6); PL (4); GB (5); NL (2); IE (1); IL (2); SL (2); LA (2)