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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04852679
Other study ID # D-CN-52030-411
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 24, 2021
Est. completion date January 13, 2023

Study information

Verified date January 2023
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs. 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, approximately five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date January 13, 2023
Est. primary completion date June 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Capable of giving signed informed consent - 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: - Participants with poorly differentiated Gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC), high-grade GEP-NEC and goblet cell carcinoid. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lanreotide autogel
Administered as deep subcutaneous (SC) injections

Locations

Country Name City State
China Beijing Cancer Hospital Beijing
China Cancer Hospital Chinese Academy of Sciences Beijing
China Peking University Third Hospital Beijing
China The First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong
China The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou Zhejiang
China The second affiliated hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital Harbin Helongjiang
China The First Affiliated Hospital of Zhengzhou University Henan Zhengzhou
China Qilu Hospital Of Shandong University Jinan Shandong
China Fudan University Shanghai Cancer Centre Shanghai
China Zhongshan Hospital Affiliated to Fudan University Shanghai
China The First Affiliated Hospital Of Xi'an Jiaotong University Shanxi Xi-an
China West China Hospital of Sichuan University Sichuan Chengdu
China Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Benefit Rate (CBR) of tumour response assessed using RECIST (Version 1.1) and confirmed by Blinded independent central review (BICR) CBR is defined as the proportion of participants with a best overall response of confirmed Complete Response (CR), confirmed Partial Response (PR), or continued Stable Disease (SD) until the time of assessment. Week 24
Secondary Progression Free Survival (PFS) within 24 and 48 weeks after first administration of study intervention PFS is defined as the time from the first administration of study intervention to the date of the first documented Progressive Disease (PD) measured using RECIST (Version 1.1) and confirmed by BICR, or death from any cause, whichever comes first. Week 24 and 48
Secondary Overall Survival (OS) at the end of the main study OS is defined as the time from the first administration of study intervention to the date of death from any cause. Up to 48 weeks (end of main study)
Secondary Time to Progression (TTP) within 48 weeks after first administration of study intervention TTP is defined as the time from the first administration of study intervention to the date of the first documented PD, or clinical progression confirmed by the investigator. Up to 48 weeks (end of study)
Secondary Proportion of participants alive and without tumour progressive at W24 and W48 Week 24 and 48
Secondary CBR CBR is defined as the proportion of participants with a best overall response of confirmed CR, confirmed PR, or continued SD until the time of assessment. Week 48
Secondary Overall Response Rate (ORR) ORR is the proportion of participants with a best overall response of confirmed CR or confirmed PR. Week 24 and 48
Secondary Disease Control Rate (DCR) DCR is the proportion of participants with a best overall response of confirmed CR, confirmed PR or SD. Week 24 and 48
Secondary Change from baseline in NET-related clinical symptoms Week 24 and 48
Secondary Change from baseline in plasma Chromogranin A (CgA) Week 12, 24, 36 and 48
Secondary Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) Week 12, 24, 36 and 48
Secondary Change from baseline in Quality of Life (QoL) assessment Day 1, week 12, 24, 36 and 48.
Secondary Incidence of Adverse Events (AEs) AEs assessed through laboratory tests, physical examination, vital signs, and medical tests. Up to 48 weeks.
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