CompletedPhase 3

Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs

China43 participantsStarted 2021-05-24

Plain-language 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, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24

Trial details

NCT IDNCT04852679

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-10

Results submitted2023-11-30