Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
NCT ID: NCT04852679
Last Updated: 2024-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
43 participants
INTERVENTIONAL
2021-05-24
2023-01-13
Brief Summary
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The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lanreotide Autogel 120 mg
Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days).
Lanreotide autogel
Administered as deep subcutaneous (SC) injections
Interventions
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Lanreotide autogel
Administered as deep subcutaneous (SC) injections
Eligibility Criteria
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Inclusion Criteria
* Male or female of 18 years of age or older when informed consent is obtained
* Has a histologically proven Grade 1 or 2 GEP-NET according to WHO (World Health Organisation) classification
* Has an unresectable metastatic or locally advanced NET.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 2.
Exclusion Criteria
* Has been treated with octreotide acetate long-acting release or lanreotide acetate Autogel formulation within 8 weeks prior to screening tests or lanreotide PR 40 mg within 4 weeks prior to screening tests.
* Has been treated with subcutaneous or intravenous octreotide acetate within 1 week prior to screening tests.
* Has been treated with mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase (MTK) inhibitors within 4 weeks prior to screening tests.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Cancer Hospital Chinese Academy of Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Qilu Hospital Of Shandong University
Jinan, Shandong, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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D-CN-52030-411
Identifier Type: -
Identifier Source: org_study_id
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