Malignant Carcinoid SyndromePhase 3NCT00092287
Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
A Phase 3 study testing lanreotide Autogel (somatostatin analogue) and Sandostatin long acting release (LAR) Depot (somatostatin analogue) in people with Malignant Carcinoid Syndrome, run by Ipsen at 1 site in United States.
Trial summary
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Carcinoid Syndrome
- What is being tested?
- lanreotide Autogel (somatostatin analogue) and Sandostatin long acting release (LAR) Depot (somatostatin analogue)
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type.
- Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut.
- Previous positive Octreoscan.
- World Health Organization (WHO) performance score lower than 2.
- At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment:
- Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average over a minimum five consecutive days).
- Patients who have previously been treated with somatostatin analogues must have discontinued treatment for a sufficient period of time (a washout period of at least 7 days for immediate release formulations and up to 2 months for prolonged release formulations is usually required). Compared with their "controlled" state on treatment, these patients must show a clinically significant deterioration (at least two episodes) of either symptom. For example, a patient considered to be controlled on their previous treatment with an estimated stool frequency of two episodes per day, must achieve a stool frequency of at least four episodes per day (average over a minimum five consecutive days).
- WHO performance score lower than 2.
Who cannot join
- VIPoma or other non-carcinoid tumor.
- Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study.
- Radionuclide treatment within three months prior to inclusion, or planned during the study.
- Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus).
- Surgical procedure or embolization procedure (with or without cytotoxic agents) of the tumor within three months prior to inclusion, or planned during the study.
- Life expectancy of less than 6 months.
- Any investigational drug given within 30 days prior to inclusion or expected to be given during the study.
- No access to a telephone for completion of the daily telephone diary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide Autogel® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.
- Conditions
- Malignant Carcinoid Syndrome
- Being tested
- lanreotide Autogel (somatostatin analogue), Sandostatin long acting release (LAR) Depot (somatostatin analogue)
- Keywords
- Carcinoid Syndrome, Neuroendocrine Tumuors
- Medical subject headings
- Malignant Carcinoid Syndrome, Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanreotide Autogel (somatostatin analogue)Drug
Sandostatin long acting release (LAR) Depot (somatostatin analogue)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Target symptom frequency (flushing or stool frequency).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2004 (estimated)
- Study startJul 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Carcinoid SyndromeStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092287
- Sponsor's protocol ID
- 2-47-52030-722
- Other IDs
- 2004-001091-40, 2004
- Status last verified
- Apr 2020
- First submitted
- 22 Sep 2004
- Last updated
- 30 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide Autogel® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
- ClinicalTrials.gov ID
- NCT00092287
- Acronym / sponsor ID
- 2-47-52030-722
- Conditions
- Malignant Carcinoid Syndrome
- Keywords
- Carcinoid Syndrome, Neuroendocrine Tumuors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Oct 2004 (actual)
- First posted
- 27 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type.
- Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to a primary tumor of the lung, stomach or mid-gut.
- Previous positive Octreoscan.
- World Health Organization (WHO) performance score lower than 2.
- At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment:
Key exclusion criteria (8 listed)
- VIPoma or other non-carcinoid tumor.
- Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study.
- Radionuclide treatment within three months prior to inclusion, or planned during the study.
- Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus).
- Surgical procedure or embolization procedure (with or without cytotoxic agents) of the tumor within three months prior to inclusion, or planned during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanreotide Autogel (somatostatin analogue) | Drug | – |
| Sandostatin long acting release (LAR) Depot (somatostatin analogue) | Drug | – |
Primary outcome
Target symptom frequency (flushing or stool frequency).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
Related trials for Malignant Carcinoid Syndrome
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 3
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Carcinoid Syndrome, Carcinoid
Active, not recruitingEarly Phase 1
An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors
Carcinoid Syndrome, Carcinoid Tumor
Active, not recruiting
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
Tricuspid Regurgitation, Tricuspid Valve Disease
Not yet recruitingObservational study
CardioNETPOL National Registry of Carcinoid Heart Disease
Carcinoid Heart Disease, Neuroendocrine Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lanreotide Autogel (somatostatin analogue) and Sandostatin long acting release (LAR) Depot (somatostatin analogue) in people with Malignant Carcinoid Syndrome, run by Ipsen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target symptom frequency (flushing or stool frequency).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.