Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398444
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-05-01
Brief Title:
A Clinical Study to Evaluate the Safety and Efficacy of Lutetium177Lu Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
Sponsor:
Sinotau Pharmaceutical Group
Organization:
Sinotau Pharmaceutical Group
Study Overview
Official Title:
A Clinical Study to Evaluate the Safety and Efficacy of Lutetium177Lu Oxodotreotide Injection in Patients With Advanced Somatostatin Receptor Positive Neuroendocrine Neoplasms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter single-arm two-part study designed to evaluate the safety and efficacy of Lutetium 177Lu Oxyoctreotide Injection in patients with inoperable locally advanced or metastatic progressive advanced somatostatin receptor SSTR positive neuroendocrine neoplasms NEN other than grade G1G2 gastroenteropancreatic neuroendocrine tumors GEP-NET
Detailed Description:
This study consists of two parts the exploratory study Part 1 and the pivotal study Part 2
In both parts participants who signs Informed consent form ICF and is eligible for the study will be enrolled Participants will receive 74GBq 200mCi Lutetium 177Lu Oxyoctreotide every 8 weeks The objective tumor response will be assessed every 12 weeks from the time of the first dose according to RECIST 11 until disease progression
In both parts participants who signs Informed consent form ICF and is eligible for the study will be enrolled Participants will receive 74GBq 200mCi Lutetium 177Lu Oxyoctreotide every 8 weeks The objective tumor response will be assessed every 12 weeks from the time of the first dose according to RECIST 11 until disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None