Trial · NCT01018953
Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
NCT01018953, Phase 2, Terminated, Ipsen; results first posted 2015-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome. Trials, record NCT01018953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01018953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
- NCT number
- NCT01018953
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Carcinoid Syndrome
- Interventions
- BIM 23A760
- First posted
- 2009-11-25
- Last updated
- 2020-11-20
- Other registries' IDs
- eudract:2009-013222-16
- Results first posted
- 2015-09-07
- Limitations and caveats
- Due to premature termination of the study, no data was collected/analyzed and no patient participated in Part B.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale | Week 24 | Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied) |
| Secondary | Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) | Up to week 24 | |
| Secondary | Change in the Quality of Life (QoL) Assessment | Week 24 | |
| Secondary | Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A | Week 24 | |
| Secondary | Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | Up to week 26 | |
| Secondary | Minimum Concentration (Cmin) BIM 23A760 Plasma Levels | 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 | At 8 timepoints up to week 24 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale | Week 24 | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | ||
| SECONDARY | Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) | Up to week 24 | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | ||
| SECONDARY | Change in the Quality of Life (QoL) Assessment | Week 24 | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | ||
| SECONDARY | Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A | Week 24 | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | ||
| SECONDARY | Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | Up to week 26 | 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. | Participants | NUMBER |
| SECONDARY | Minimum Concentration (Cmin) BIM 23A760 Plasma Levels | At 9 timepoints up to 1 week after 24th administration in week 24 | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. | ||
| SECONDARY | Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels | At 8 timepoints up to week 24 | Study was prematurely terminated and no data was collected/analyzed for this outcome measure. |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | BIM 23A760 | General Disorders & Administration Site Condition | 5 | Participants | |
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | BIM 23A760 | Gastrointestinal Disorder | 4 | Participants | |
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | BIM 23A760 | Nervous System Disorders | 3 | Participants | |
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | BIM 23A760 | Infections and Infestations | 2 | Participants | |
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | BIM 23A760 | Metabolism and Nutritional Disorders | 2 | Participants | |
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | BIM 23A760 | Neoplasms Benign, Malignant and unspecified | 2 | Participants | |
| Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) | BIM 23A760 | Reproductive System and Breast Disorders | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BIM 23A760 | 8 | |
| Overall Study | BIM 23A760 1 mg | BIM 23A760 | 3 | |
| Overall Study | BIM 23A760 2 mg | BIM 23A760 | 2 | |
| Overall Study | BIM 23A760 4 mg | BIM 23A760 | 3 | |
| Overall Study | COMPLETED | BIM 23A760 | 0 | |
| Overall Study | NOT COMPLETED | BIM 23A760 | 8 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | BIM 23A760 | 2 | 8 | 2 |
| other | Fatigue | General disorders | BIM 23A760 | 1 | 8 | 1 |
| other | Injection site inflammation | General disorders | BIM 23A760 | 1 | 8 | 1 |
| other | Injection site pain | General disorders | BIM 23A760 | 1 | 8 | 3 |
| other | Injection site pruritus | General disorders | BIM 23A760 | 1 | 8 | 1 |
| other | Injection site reaction | General disorders | BIM 23A760 | 1 | 8 | 1 |
| other | Oedema | General disorders | BIM 23A760 | 1 | 8 | 1 |
| other | Nausea | Gastrointestinal disorders | BIM 23A760 | 3 | 8 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | BIM 23A760 | 2 | 8 | 2 |
| other | Constipation | Gastrointestinal disorders | BIM 23A760 | 2 | 8 | 2 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BIM 23A760 | ||
| Total, other adverse events | BIM 23A760 | 6 | 8 |
| Total, serious adverse events | BIM 23A760 | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01018953
GET https://conductscience.org/api/trials/v1/NCT01018953/events?page=2