Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04313075
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-01-28
First Post:
2020-03-16
Brief Title:
A Compassionate Use Study of Leronlimab in Breast Cancer
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
Official Title:
A Compassionate Use Study of Leronlimab PRO 140 in Combination With Treatment of Physicians Choice in Patients With CCR5 Metastatic Triple Negative Breast Cancer mTNBC
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2022-01
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 single arm compassionate use study with 30 patients for leronlimab PRO 140 combined with a treatment of physicians choice TPC in patients with CCR5 mTNBC
Detailed Description:
This is a single arm compassionate use study with 30 patients for leronlimab PRO 140 combined with a treatment of physicians choice TPC in patients with CCR5 mTNBC
Leronlimab PRO 140 will be administered subcutaneously as weekly dose of 350 mg until disease progression or intolerable toxicity Treatment of Physicians Choice TPC is defined as one of the following single-agent chemotherapy drugs administrated according to local practice eribulin gemcitabine capecitabine paclitaxel nab-paclitaxel vinorelbine ixabepilone or carboplatin The selected treatment should be administered as per the dosing schedule included on the package insert
In this study patients will be evaluated for tumor response approximately every 3 months or according to institutions standard practice by CT PETCT or MRI with contrast per treating investigators discretion using the same method as at baseline Tumor measurements will be done using RECIST v11
Leronlimab PRO 140 will be administered subcutaneously as weekly dose of 350 mg until disease progression or intolerable toxicity Treatment of Physicians Choice TPC is defined as one of the following single-agent chemotherapy drugs administrated according to local practice eribulin gemcitabine capecitabine paclitaxel nab-paclitaxel vinorelbine ixabepilone or carboplatin The selected treatment should be administered as per the dosing schedule included on the package insert
In this study patients will be evaluated for tumor response approximately every 3 months or according to institutions standard practice by CT PETCT or MRI with contrast per treating investigators discretion using the same method as at baseline Tumor measurements will be done using RECIST v11
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