Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02705313
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2018-04-09
First Post:
2016-03-07
Brief Title:
EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable SSR NETs Progressive Under SSA Tx
Sponsor:
Advanced Accelerator Applications
Organization:
Advanced Accelerator Applications
Study Overview
Official Title:
Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable Somatostatin Receptor Positive Neuroendocrine Tumors Progressive Under Somatostatin Analogue Therapy
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2018-04
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:
Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate Lutathera This expanded access therapeutic protocol aims to allow patients suffering from inoperable somatostatin receptor positive neuroendocrine tumors progressive under somatostatin analogue therapy to access the investigational product 177Lu-DOTA0-Tyr3-Octreotate Lutathera prior to its commercial availability
Detailed Description:
Advanced Accelerator Applications activated in 2012 a multicenter stratified open randomized comparator-controlled parallel-group Phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to 60 mg Octreotide LAR in patients with inoperable progressive somatostatin receptor positive midgut carcinoid tumors NETTER-1 trial EudraCT number 2011-005049-11 IND number 77219
Clinical studies including NETTER-1 for which the primary analysis has been conducted showed clinical evidence of safety and effectiveness to support the expanded access use without any unreasonable potential risks for the patients in the context of the disease to be treated
In July 2016 the first patient was treated under an Expanded Access Program EAP for inoperable progressive somatostatin receptor positive midgut carcinoid tumors
Compassionate use programs in Europe include pulmonary NETs In the US there were many centers with patients with NETs who did not meet the inclusion criteria for the original EAP In May 2017 Advanced Accelerator Applications inquired with the FDA if amending the inclusion criteria of the original protocol to include all NETs would be permissible
In June 2017 Advanced Accelerator Applications was able to submit a revision to the original Expanded Access Programs protocol for 177Lu-DOTA0-Tyr3-Octreotate to include neuroendocrine tumors arising from sites other than midgut
The locations listed below that are participating in the EAP may have received IRB approval for either the original protocol or the new protocol or both Please inquire with the Facility Contact as to which protocol is active at their site
Clinical studies including NETTER-1 for which the primary analysis has been conducted showed clinical evidence of safety and effectiveness to support the expanded access use without any unreasonable potential risks for the patients in the context of the disease to be treated
In July 2016 the first patient was treated under an Expanded Access Program EAP for inoperable progressive somatostatin receptor positive midgut carcinoid tumors
Compassionate use programs in Europe include pulmonary NETs In the US there were many centers with patients with NETs who did not meet the inclusion criteria for the original EAP In May 2017 Advanced Accelerator Applications inquired with the FDA if amending the inclusion criteria of the original protocol to include all NETs would be permissible
In June 2017 Advanced Accelerator Applications was able to submit a revision to the original Expanded Access Programs protocol for 177Lu-DOTA0-Tyr3-Octreotate to include neuroendocrine tumors arising from sites other than midgut
The locations listed below that are participating in the EAP may have received IRB approval for either the original protocol or the new protocol or both Please inquire with the Facility Contact as to which protocol is active at their site
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