CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 43 enrolled
Drug / intervention
Lanreotide autogeldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04852679
NCT04852679Phase 3Completed
CompareCT.gov

A Phase 3, Single-arm, Open-label, Multicentre Study to Assess the Efficacy and Safety of Deep Subcutaneous Injections of Lanreotide Autogel® 120 mg Administered Every 28 Days in Chinese Participants With Unresectable, Locally Advanced or Metastatic Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)

Ipsen·interventional·Posted Apr 21, 2021·Updated Oct 1, 2024

In Brief

A Phase 3 clinical trial evaluating Lanreotide autogel for Gastroenteropancreatic Neuroendocrine Tumor. Completed, enrolled 43 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroenteropancreatic Neuroendocrine Tumor
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedApr 21, 2021
Enrollment StartMay 24, 2021
Primary CompletionJun 10, 2022
Study CompletionJan 13, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.2 years ago

Interventions

Lanreotide autogeldrug

Administered as deep subcutaneous (SC) injections