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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 G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET).
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 7.4GBq (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 1.1 until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutetium[177Lu] Oxodotreotide Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutetium[177Lu] Oxodotreotide Injection | Drug | Participants will receive 7.4GBq (200mCi) Lutetium[177Lu] Oxodotreotide Injection every 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AE) (Part1) | Until 6 months after the last dose | |
| Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2) | Until disease progression or death, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) (Part 1) | Until disease progression or death, up to 5 years | |
| Progression-free survival (PFS) (Part 1) | Until disease progression or death, up to 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| C447941 | lutetium Lu 177 dotatate |
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| Disease Control Rate (DCR) (Part 1) |
| Until disease progression or death, up to 5 years |
| Duration of Overall Response (DoR) (Part 1) | Until disease progression or death, up to 5 years |
| Time to Progression (TTP) (Part 1) | Until disease progression or death, up to 5 years |
| PFS rate at 12 months (Part 1) | At 12 months after the first dose |
| Overall Survival (OS) (Part 1) | Until death of any cause, up to 5 years |
| Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 1) | Until disease progression or death, up to 5 years |
| Change From Baseline in the EORTC Quality of Life Questionnaire (Part 1) | Until disease progression or death, up to 5 years |
| Progression-free survival (PFS) (Part 2) | Until disease progression or death, up to 5 years |
| Disease Control Rate (DCR) (Part 2) | Until disease progression or death, up to 5 years |
| Duration of Overall Response (DoR) (Part 2) | Until disease progression or death, up to 5 years |
| Time to Progression (TTP) (Part 2) | Until disease progression or death, up to 5 years |
| PFS rate at 12 months (Part 2) | At 12 months after the first dose |
| Overall Survival (OS) (Part 2) | Until death of any cause, up to 5 years |
| Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 2) | Until disease progression or death, up to 5 years |
| Change From Baseline in the EORTC Quality of Life Questionnaire (Part 2) | Until disease progression or death, up to 5 years |
| Incidence and severity of AE (Part2) | Until 6 months after the last dose |