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

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ClinicalTrials.gov Identifier: NCT01018953
Recruitment Status : Terminated (Preliminary data from study NCT00994214 do not support expected inhibition of GH and IGF-1)
First Posted : November 25, 2009
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Carcinoid Syndrome Drug: BIM 23A760 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2010
Primary Completion Date : December 2010
Study Completion Date : January 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: BIM 23A760
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
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.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale [ Time Frame: Week 24 ]
    Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)


Secondary Outcome Measures :
  1. Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) [ Time Frame: Up to week 24 ]
  2. Change in the Quality of Life (QoL) Assessment [ Time Frame: Week 24 ]
  3. Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A [ Time Frame: Week 24 ]
  4. Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) [ Time Frame: Up to week 26 ]
  5. Minimum Concentration (Cmin) BIM 23A760 Plasma Levels [ Time Frame: At 9 timepoints up to 1 week after 24th administration in week 24 ]
  6. Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels [ Time Frame: At 8 timepoints up to week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018953


  Show 54 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Catherine Lesage, MD Ipsen
More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01018953     History of Changes
Other Study ID Numbers: 8-55-52060-004
First Posted: November 25, 2009    Key Record Dates
Results First Posted: September 7, 2015
Last Update Posted: September 7, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Syndrome
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Dopamine
Somatostatin
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists