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Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients (CALM-NET)

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ClinicalTrials.gov Identifier: NCT02075606
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:

Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are secreting hormones and are located in the area in the middle of the digestive system) and their presence usually means that the prognosis for the patient is poor. CTCs have also been shown to be valuable as predictive markers following treatment and there is increasing interest in using CTCs as 'liquid biopsies' that can help to inform treatment decisions. CTC analysis has the benefit of being relatively non- invasive and quick compared with a conventional CT scan and is therefore an attractive method of monitoring the tumour throughout the treatment period.

The purpose of this study is to assess the clinical value that enumeration will have in predicting the clinical symptomatic response and progression free survival in patients receiving Somatuline Autogel for functioning midgut NETs over a one year period.


Condition or disease Intervention/treatment Phase
NeuroEndocrine Tumours Drug: lanreotide acetate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase IV, Multicentre, Open Label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients Receiving Deep Subcutaneous Administrations of Somatuline® (Lanreotide) Autogel® to Treat the Symptoms of Functioning Midgut NeuroEndocrine Tumours (NET)
Study Start Date : May 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Somatuline Autogel®
Somatuline Autogel® to treat Functioning Midgut NeuroEndocrine Tumours (NET)
Drug: lanreotide acetate
Somatuline Autogel injection 120mg for first 3 months then 120, 90 or 60 mg administered via the deep subcutaneous route every 28 days




Primary Outcome Measures :
  1. Enumeration of CTCs [ Time Frame: Week 1 ]
    Assessment of the clinical value of enumeration of circulating tumour cells (CTCs) to predict clinical symptomatic response in patients receiving Somatuline Autogel.


Secondary Outcome Measures :
  1. Enumeration of CTCs [ Time Frame: Weeks 5, 17, 25 and 53 ]
    Assessment of the clinical value of enumeration of circulating tumour cells (CTCs) to predict clinical symptomatic response in patients receiving Somatuline Autogel.

  2. Symptoms of diarrhoea and flushing in patients with a functioning NET [ Time Frame: 1 year ]
    Effect assessed by symptom frequency, severity and CTC presence (CTCs>0).

  3. Quality of Life [ Time Frame: 1 year ]
    Quality of Life assessed using scores from specific NET patient questionnaires (EORTC QLQ-NET21 and QLQ-C30).

  4. Progression Free Survival [ Time Frame: 1 year ]
    Progression Free Survival measured using Response Evaluation Criteria Solid Tumours (RECIST) criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent prior to any study related procedures.
  • Patients (either sex) must be 18 years or older.
  • Patients must be suffering from symptoms of diarrhoea and/or flushing at the time of study enrolment.
  • Patients must have a documented diagnosis of a functioning midgut NET.
  • In order to avoid patients with rapidly progressing tumours, only patients with well or moderately differentiated tumours and with a Ki67 proliferation index of <20% will be recruited.
  • The clinically appropriate treatment for the patient must be therapy with a somatostatin analogue.
  • Patients must have had either a positive somatostatin receptor scintigraphy result or a positive 68Gallium-DOTATATE PET imaging result.

Exclusion Criteria:

  • If the patient is at risk of pregnancy or is breast feeding, unless treatment with Somatuline Autogel is clearly needed (as determined by the clinician).
  • The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
  • The patient has been treated with any other unlicensed drug within the last 30 days before study entry or will require a concurrent treatment with any other experimental drugs or treatments.
  • The patient has been treated with a somatostatin analogue prior to study entry, unless a washout period of at least 2 weeks for subcutaneous octreotide, or at least 6 weeks for a single dose of long acting somatostatin analogue has occurred.
  • The patient has received interferon, chemotherapy, chemoembolisation or radionuclide therapy within 3 months prior to study entry.
  • The patient has a history of hypersensitivity to drugs with a similar chemical structure.
  • Females of childbearing potential must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as being post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
  • The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

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): NCT02075606


Locations
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United Kingdom
Basingstoke & North Hampshire Hospital
Basingstoke, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital Wales
Cardiff, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St James's University Hospital
Leeds, United Kingdom
University Hospital Aintree
Liverpool, United Kingdom
Hammersmith Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Norfolk & Norwich Hospital
Norwich, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Southampton University Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Matthew Hickling, MD Ipsen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02075606     History of Changes
Other Study ID Numbers: A-97-52030-270
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Ipsen:
NET
Symptomatic response
Functioning NeuroEndocrine Tumours
midgut region

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasm Metastasis
Neoplastic Cells, Circulating
Neoplastic Processes
Pathologic Processes
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs