Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-07 @ 10:36 PM
Study NCT ID:
NCT04465760
Status:
TERMINATED
Last Update Posted:
2024-01-24
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient accrual rate
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well xisomab 3G3 works in preventing catheter-associated blood clots (thrombosis) in patients with cancer receiving chemotherapy. Many patients with cancer develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Xisomab 3G3 is type of drug called a monoclonal antibody that may prevent blood clots caused by a catheter in patients receiving chemotherapy.
Detailed Description:
PRIMARY OBJECTIVE I. To determine the efficacy of xisomab as measured by the incidence of catheter-associated thrombosis (CAT) in individuals with a central venous catheter.
SECONDARY OBJECTIVE:
I. To evaluate the safety and tolerability of xisomab 3G3 in cancer patients with a PICC or indwelling catheter.
EXPLORATORY OBJECTIVE:
I. Assessment of drug exposure and catheter occlusions leading to medical intervention.
OUTLINE:
Patients receive xisomab 3G3 intravenously (IV) or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
After completion of study, patients are followed up for 60 days.
SECONDARY OBJECTIVE:
I. To evaluate the safety and tolerability of xisomab 3G3 in cancer patients with a PICC or indwelling catheter.
EXPLORATORY OBJECTIVE:
I. Assessment of drug exposure and catheter occlusions leading to medical intervention.
OUTLINE:
Patients receive xisomab 3G3 intravenously (IV) or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
After completion of study, patients are followed up for 60 days.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-02554 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STUDY00018976 | OTHER | OHSU Knight Cancer Institute | View | |
| R01HL151367 | NIH | None | https://reporter.nih.gov/quic… | View |