Symptoms and General Pathology

All Conditions

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Rare Diseases

Syndrome

Carcinoid Tumor

Malignant Carcinoid Syndrome

Serotonin Syndrome

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Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Carcinoid Syndrome

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

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).

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

Ipsen Medical Director

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.

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

Phase II, Open, Adaptive, Dose Escalating, Multicentre Titration Study to Assess the Efficacy and Safety of Repeated Subcutaneous Administration of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)

Ipsen

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.

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.

Age, Continuous

Between 18 and 75 years

Age, Customized

Sex: Female, Male

Caucasian/ White

Race/Ethnicity, Customized

Russian Federation

United Kingdom

Netherlands

Belgium

Ireland

Finland

Germany

Region of Enrollment

Diabetic

Nondiabetic

Diabetic status

N/A - Not applicable

Post-menopausal status

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

Medical Director, Oncology

Study was prematurely terminated and no data was collected/analyzed for this outcome measure.

Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale

Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)

Change in the Quality of Life (QoL) Assessment

Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A

General Disorders & Administration Site Condition

Gastrointestinal Disorder

Nervous System Disorders

Infections and Infestations

Metabolism and Nutritional Disorders

Neoplasms Benign, Malignant and unspecified

Reproductive System and Breast Disorders

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.

Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)

Minimum Concentration (Cmin) BIM 23A760 Plasma Levels

Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels

Overall Study

Spots Global Cancer Trial Database for bim 23a760

Every month we try and update this database with for bim 23a760 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bim 23a760

Every month we try and update this database with for bim 23a760 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bim 23a760 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.