Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505395
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
A Trial to Assess Efficacy Safety Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor GEP-NET
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None