NCT06505395

A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)

A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.

Detailed description

This is a Phase II, open-label randomized study to assess the PK, efficacy, and safety of SYHX2008 in adult patients with well-differentiated GEP-NET. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres cohort (Sandostatin LAR@).

Conditions

• Gastrointestinal Neuroendocrine Pancreatic Tumor

Interventions

Type	Name	Description
DRUG	SYHX2008 injection	The patients will accept SYHX2008 injection by subcutaneous administration every cycle.
DRUG	Sandostatin LAR@	The patients will accept Sandostatin LAR@ by intra-muscular administration every cycle.

Timeline

• Start date: 2024-07-30
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2024-07-17
• Last updated: 2024-08-26

Locations

1 site across 1 country: China