Status:
COMPLETED
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
Lead Sponsor:
Ipsen
Conditions:
Gastroenteropancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04852679
Start Date
May 24 2021
End Date
January 13 2023
Last Update
October 1 2024
Active Locations (14)
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1
Cancer Hospital Chinese Academy of Sciences
Beijing, Beijing Municipality, China, 100021
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
4
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080