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Study of Lanreotide in Metastatic or Recurrent Grade I-II Hindgut NET

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03083210
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : May 20, 2019
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center

Brief 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 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Lanreotide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Lanreotide
Lanreotide, at a dose of 120mg will be administered without dose adjustment, by means of deep subcutaneous injection every 28 days.
Drug: Lanreotide
Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT03083210

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Contact: YOUNGSUK PARK, M.D., Ph.D 82-2-3410-3459

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Korea, Republic of
Youngsuk Park Recruiting
Seoul, Korea, Republic of, 06351
Contact: sungju park   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Young Suk Park, Professor, Samsung Medical Center Identifier: NCT03083210     History of Changes
Other Study ID Numbers: 2016-11-017
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs