Neuroendocrine TumorsPhase 4NCT03083210
Study of Lanreotide in Metastatic or Recurrent Grade I-II Hindgut NET
A Phase 4 study testing Lanreotide in people with Neuroendocrine Tumors, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Clinical data from uncontrolled retrospective or prospective studies have initially demonstrated antiproliferative effects of lanreotide in limited number of patients lanreotide Autogel® has recently been approved in more than 40 countries for the treatment of GEP-NET patients, this is based on the results of CLARINET… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Lanreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2017to Feb 2020
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed well differentiated or moderate differentiated neuroendocrine tumor. WHO 2010 Grade 1 or 2
- Age >20
- Measurable disease by RECIST v 1.0
- Primary tumor were located in hindgut, colorectal areas.
- Non functioning or functioning NETs
- Unresectable locally advanced or metastatic disease
Who cannot join
- Prior receiving systemic therapies including interferon, chemotherapy, PRRT, chemoembolization or a somatostatin analogue at any time (unless they had received it >6 months previously and for <15 days).
- Multiple endocrine neoplasia
- Previous cancer except in the case of patients with treated or untreated in situ cervical or uterine carcinoma or basal cell skin cancer or patients with other cancers who had been treated with curative intent and had been disease free for > 5 years
- Foregut, midgut, and pancreatic NETs and NETs of unknown primary origin Cross reference: Hindgut: Distal 1/3rd transverse colon, descending colon, sigmoid colon, rectum, upper anal canal
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Youngsuk Park
Seoul, 06351
sungju park, sungju6820.park@samsung.com
About this study
Official title: PILOT STUDY OF LANREOTIDE IN METASTATIC OR RECURRENT GRADE I-II HINDGUT NET
Clinical data from uncontrolled retrospective or prospective studies have initially demonstrated antiproliferative effects of lanreotide in limited number of patients lanreotide Autogel® has recently been approved in more than 40 countries for the treatment of GEP-NET patients, this is based on the results of CLARINET study, the largest prospective trial to evaluate the antiproliferative effects of lanreotide Autogel® in subjects with nonfunctional GEP-NETs. The study enrolled 204 subjects (101 subjects were randomized to lanreotide Autogel® group and 103 subjects were randomized to placebo group, came from 14 countries) with well or moderately differentiated non-functioning GEP-NETs, including pancreatic and gastrointestinal tumors, and defined as having less than 10% of proliferation marker Ki67. The study had shown that treatment with lanreotide Autogel® significantly prolonged progression-free survival in subjects with GEP-NETs compared to treatment with placebo in the primary analysis (median progression-free survival, not reached vs. 18.0 months, P< 0.001 by the stratified log-rank test; hazard ratio for progression or death with lanreotide vs. placebo, 0.47; 95% confidence interval (CI), 0.30 to 0.73) [5].
The indication of GEP-NETs granted for lanreotide Autogel® in the USA is for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; and in the European Union (EU) is for treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease. The addition of an indication for the treatment of patients with GEP-NETs has been approved by more than 15 other authorities including in Canada, Australia and some Asian countries, etc.
Read the detailed description
Patients with advanced hindgut NET who don't receive prior systemic therapies will receive laneotide. Study-arm is composed of 28 patients. Laneotide 120mg s.c. once every a 28 day.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Lanreotide
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanreotideDrug
Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Lanreotide | Experimental | Lanreotide, at a dose of 120mg will be administered without dose adjustment, by means of deep subcutaneous injection every 28 days. Receives: Drug: Lanreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start5 Jul 2017
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Suk Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083210
- Sponsor's protocol ID
- 2016-11-017
- Status last verified
- May 2019
- First submitted
- 15 Feb 2017
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT STUDY OF LANREOTIDE IN METASTATIC OR RECURRENT GRADE I-II HINDGUT NET
- ClinicalTrials.gov ID
- NCT03083210
- Acronym / sponsor ID
- 2016-11-017
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 17 Mar 2017 (actual)
- 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.
Clinical data from uncontrolled retrospective or prospective studies have initially demonstrated antiproliferative effects of lanreotide in limited number of patients lanreotide Autogel® has recently been approved in more than 40 countries for the treatment of GEP-NET patients, this is based on the results of CLARINET study, the largest prospective trial to evaluate the antiproliferative effects of lanreotide Autogel® in subjects with nonfunctional GEP-NETs. The study enrolled 204 subjects (101 subjects were randomized to lanreotide Autogel® group and 103 subjects were randomized to placebo group, came from 14 countries) with well or moderately differentiated non-functioning GEP-NETs, including pancreatic and gastrointestinal tumors, and defined as having less than 10% of proliferation marker Ki67. The study had shown that treatment with lanreotide Autogel® significantly prolonged progression-free survival in subjects with GEP-NETs compared to treatment with placebo in the primary analysis (median progression-free survival, not reached vs. 18.0 months, P< 0.001 by the stratified log-rank test; hazard ratio for progression or death with lanreotide vs. placebo, 0.47; 95% confidence interval (CI), 0.30 to 0.73) [5].
The indication of GEP-NETs granted for lanreotide Autogel® in the USA is for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; and in the European Union (EU) is for treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease. The addition of an indication for the treatment of patients with GEP-NETs has been approved by more than 15 other authorities including in Canada, Australia and some Asian countries, etc.
Detailed description
Patients with advanced hindgut NET who don't receive prior systemic therapies will receive laneotide. Study-arm is composed of 28 patients. Laneotide 120mg s.c. once every a 28 day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.
| Arm | Type | Receives |
|---|---|---|
| Lanreotide | Experimental | Drug: LanreotideLanreotide, at a dose of 120mg will be administered without dose adjustment, by means of deep subcutaneous injection every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed well differentiated or moderate differentiated neuroendocrine tumor. WHO 2010 Grade 1 or 2
- Age >20
- Measurable disease by RECIST v 1.0
- Primary tumor were located in hindgut, colorectal areas.
- Non functioning or functioning NETs
Key exclusion criteria (4 listed)
- Prior receiving systemic therapies including interferon, chemotherapy, PRRT, chemoembolization or a somatostatin analogue at any time (unless they had received it >6 months previously and for <15 days).
- Multiple endocrine neoplasia
- Previous cancer except in the case of patients with treated or untreated in situ cervical or uterine carcinoma or basal cell skin cancer or patients with other cancers who had been treated with curative intent and had been disease free for > 5 years
- Foregut, midgut, and pancreatic NETs and NETs of unknown primary origin Cross reference: Hindgut: Distal 1/3rd transverse colon, descending colon, sigmoid colon, rectum, upper anal canal
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 |
|---|---|---|
| LanreotideLanreotide, at a dose of 120mg subcutaneous injection every 28 days. | Drug | Lanreotide |
Primary outcome
Progression free survival
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lanreotide in people with Neuroendocrine Tumors, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2019. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YOUNGSUK PARK, M.D., Ph.D (82-2-3410-3459, pys27hmo.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: up to 12 months). 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 20 May 2019.