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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Treatments

Drug: Lanreotide autogel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04852679

D-CN-52030-411

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.