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
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