Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460298
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Brief Title:
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
Sponsor:
ProDa BioTech LLC
Organization:
ProDa BioTech LLC
Study Overview
Official Title:
Phase III Trial Evaluating the Safety and Efficacy of ProAgio an Anti- αvβ3 Integrin Cytotoxin in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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 Phase III Trial Evaluating the Safety and Efficacy of ProAgio an anti- αvβ3 Integrin Cytotoxin in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer
Detailed Description:
This is a single-arm Phase III study designed to evaluate the safety and efficacy of the combination of ProAgio with gemcitabine in patients with previously treated metastatic triple negative breast cancer
Dose escalation will proceed using the Bayesian Optimal Interval BOIN design with a target toxicity rate of 025 a maximum sample size of 20 and a cohort size of 2
There are four dose levels considered in the dose escalation phase and we start at the lowest dose level Dose Level 1
Dose escalation will proceed using the Bayesian Optimal Interval BOIN design with a target toxicity rate of 025 a maximum sample size of 20 and a cohort size of 2
There are four dose levels considered in the dose escalation phase and we start at the lowest dose level Dose Level 1
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