Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Oculocerebral Syndrome With Hypopigmentation

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Lanreotide

lanreotide (Autogel formulation)

Ipsen Medical Director

The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource utilisation and costs will be studied. In addition, we will also assess the healthcare provider's experience of the two administration practices.

Somatuline Autogel Preference and Health Economy Study

A Phase IV, International, Open-label, Randomised, Cross-over Study to Assess Patient Preference and Health Economy in Patients With Neuroendocrine Tumours, Treated With Lanreotide Autogel Given as Self Administration.

A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection

The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'

The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'

Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).

Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.

Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.

Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.

Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.

'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.

'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.

'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.

'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.

Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.

'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.

'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.

'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.

'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.

Assessed by the number of HCP with a positive response 'yes' to two questions:

1. Based on your experience during this trial, did you feel confident in the safety of your patients?
2. Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?

Ipsen

The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.

Training Period

The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.

Self or Partner Administration

A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.

HCP Administration

Self or partner administration followed by HCP administration.

Group 1 Self or Partner First Then HCP Administration

Administration by HCP then self or partner administration.

Group 2 HCP Then Self or Partner Administration

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Denmark

Norway

Sweden

Region of Enrollment

Medical Director, Endocrinology

Self or Partner Administration followed by HCP Administration.

Administration by HCP then Self or Partner Administration.

Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded

Subject Preference for Self or Partner Administration

Number of Patients Stating at Least One Injection Interfered With Daily Activities

Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing

The self or partner administration block (after the training period) included three unsupervised injections every 28th day at the subject's home.

Safety population: all randomised subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.

Days Sick Leave

The self or partner administration block (after the training) included three unsupervised injections every 28th day at the subject's home.

Safety population: all randomised subjects with at least one dose of study medication

Total Number of Visits to HCP Due to Carcinoid Symptoms

Worsened

Similar

Improved

Missing

Baseline refers to the last non-study visit at the clinic.

Baseline

Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.

Perceived Symptom Control Evaluation in Respect to Episodes of Flushing

Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea

Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.

Before Self or Partner Administration

After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.

After Self or Partner Administration

Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.

Before HCP Administration

After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.

After HCP Administration

ITT population that had hormone levels assessed at each administration block.

Chromogranin A Levels

5-HIAA were assessed as judged necessary by the investigator at each site.

5-hydroxyindoleacetic Acid (5-HIAA) Levels

One HCP from each site who enrolled participants answered the questions

Overall Study Group

One HCP from each site who enrolled participants replied to the question

Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method

Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject's home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day.

Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject's home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection.

Spots Global Cancer Trial Database for Somatuline Autogel Preference and Health Economy Study

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Study Description

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