clinical trial · NCT06505395
A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·phase2·recruiting·n = 90
Gastrointestinal Neuroendocrine Pancreatic TumorSYHX2008 injectionSandostatin LAR@
brief 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.
started
Jul 30, 2024
primary completion
Aug 1, 2027
completion
Aug 1, 2028
last updated
Aug 26, 2024
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@).
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol