Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04476797
Status:
TERMINATED
Last Update Posted:
2024-04-30
First Post:
2020-07-15
Brief Title:
Phase III Study of SBRT and GC4711 for Centrally Located or Large NSCLC
Sponsor:
Galera Therapeutics Inc
Organization:
Galera Therapeutics Inc
Study Overview
Official Title:
GRECO-1 Phase III Randomized Placebo-Controlled Study of Stereotactic Body Radiation Therapy SBRT and GC4711 for Centrally Located or Large Node-Negative Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Development GC4711 was halted after the lead study in pancreatic cancer was stopped early due to meeting the requirements of a futility analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRECO-1
Brief Summary:
GTI-4711-101 is a Phase III study of the safety of GC4711 its effect on in-field tumor response and its potential to reduce radiation-related pulmonary injury due to SBRT for lymph node negative T1 to T3N0M0 peripheral or central localized within 2cm of the proximal bronchial tree NSCLC
After an open-label Phase 1 safety cohort of 5 subjects has been completed a randomized placebo-controlled Phase 2 portion of 66 subjects will be conducted
After an open-label Phase 1 safety cohort of 5 subjects has been completed a randomized placebo-controlled Phase 2 portion of 66 subjects will be conducted
Detailed Description:
Subjects must be referred for SBRT with large peripheral lesions 1cm-7cm andor central localized node negative non-metastatic NSCLC and have an ECOG PS score of 0-3 Feasibility of SBRT is judged by the treating physician
SBRT is planned for the tumor location as a dose of or 3 fractions of 18-20 Gy Phase 2 only or 5 fractions of 10-12 Gy SBRT fractions will be given within 180 minutes from the end of the GC4711 or placebo infusion
After completion of Phase I a Phase II randomized placebo-controlled study will be initiated wherein approximately 66 subjects referred for SBRT with early stage large andor central localized NSCLC will be randomized in a 11 ratio to receive either GC4711 or placebo given intravenously IV over 15 minutes before each fraction of SBRT beginning the day of the first fraction of SBRT and ending the last day of SBRT
Subjects will be monitored for treatment emergent adverse events for 30 days post SBRT completion Additionally subjects will be monitored 90 days post-SBRT for all adverse events to evaluate acute toxicities and monitored for 1-year post-SBRT completion for specific late toxicities
In-field tumor response and overall survival will be evaluated through 24 months post SBRT completion
SBRT is planned for the tumor location as a dose of or 3 fractions of 18-20 Gy Phase 2 only or 5 fractions of 10-12 Gy SBRT fractions will be given within 180 minutes from the end of the GC4711 or placebo infusion
After completion of Phase I a Phase II randomized placebo-controlled study will be initiated wherein approximately 66 subjects referred for SBRT with early stage large andor central localized NSCLC will be randomized in a 11 ratio to receive either GC4711 or placebo given intravenously IV over 15 minutes before each fraction of SBRT beginning the day of the first fraction of SBRT and ending the last day of SBRT
Subjects will be monitored for treatment emergent adverse events for 30 days post SBRT completion Additionally subjects will be monitored 90 days post-SBRT for all adverse events to evaluate acute toxicities and monitored for 1-year post-SBRT completion for specific late toxicities
In-field tumor response and overall survival will be evaluated through 24 months post SBRT completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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