Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199453
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-29
Brief Title:
The Evaluation of the Effectiveness Safety and Tolerability of Treatment Using a PSMA-Lu177 in Patients With ACC- an Open Non-commercial Clinical Trial
Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Organization:
Maria Sklodowska-Curie National Research Institute of Oncology
Study Overview
Official Title:
The Evaluation of the Effectiveness Safety and Tolerability of Treatment Using a Specialized Prostate-specific Membrane Antigen PSMA Labeled With Lutetium177 in Patients With Recurrent andor Metastatic Adenoid Cystic Carcinoma Originating From the Salivary Glands - an Open Non-commercial Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
LuRM_ACC2023
Brief Summary:
Non-commercial phase 2 clinical trial to evaluate the effectiveness safety and tolerability of treatment using prostate-specific membrane antigen PSMA labeled with 177Lutetium in patients with recurrence andor metastases in adenoid cystic carcinoma originating from the salivary glands of the head and neck region
Patients with PSMA receptor expression confirmed by PETCT after administration of 68Ga-PSMA IT will be eligible for treatment
Patients with PSMA receptor expression confirmed by PETCT after administration of 68Ga-PSMA IT will be eligible for treatment
Detailed Description:
It is planned to enroll 32 patients diagnosed with non-resectable recurrence andor dissemination in the course of ACC whose general condition and life expectancy justify qualification for diagnosis using PSMA 68Ga and treatment with lutetium 177Lu vipivotide-tetraxetan
The Study assumes the administration of 6 cycles of treatment lutetium 177Lu vipivotide-tetraxetan at 6-week intervals
If toxicity occurs the activity of the next dose of the preparation will be modified or its next administration will be delayed by a maximum of 4 weeks
After completing 6 cycles of therapy the participant enters the observation phase which will last until recurrence of the disease is diagnosed or for 2 years after the end of therapy
The Study assumes the administration of 6 cycles of treatment lutetium 177Lu vipivotide-tetraxetan at 6-week intervals
If toxicity occurs the activity of the next dose of the preparation will be modified or its next administration will be delayed by a maximum of 4 weeks
After completing 6 cycles of therapy the participant enters the observation phase which will last until recurrence of the disease is diagnosed or for 2 years after the end of therapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU CT 2023-504699-73-00 | OTHER | EMA | None |