Trials Sponsors Conditions Drugs Pricing

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
+1 more secondary outcomes

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 23A760Drug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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).

Sponsors & Collaborators

Ipsen
Industrylead

Study Sites (54)

University Hospital, Internal Medicine - Oncology

Vienna, A-9010, Austria

UZ Antwerpen

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

MeSH Terms

Conditions

Serotonin Syndrome

Interventions

TBR-760

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-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

Study Officials

Ipsen Medical Director
Ipsen
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

8 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

BIM 23A760

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

BIM 23A760

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations