NCT06866964

A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to the 6-month Venous Thromboembolism (VTE)-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose acetylsalicylic acid (ASA) and compare to relevant historical controls

Detailed description

This is a single-arm, two-stage, Phase II study designed to evaluate the 6-month VTE-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose ASA as compared to relevant historical controls. Stage 1 will consist of 13 participants. If at least 9 of those 13 do not experience a VTE event during the first 26 weeks on the ASA, Stage 2 will be activated. Stage 2 will enroll an additional 18 participants for a total of 31. Participants will provide their own supply of ASA. Participants will self-administer a fixed dose of ASA (81 mg) by mouth daily for 26 weeks. Participants who experience the primary endpoint of VTE will stop ASA and start standard of care anticoagulation at the direction of the treating investigator. This study will initially open as a single center study at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) and additional investigational site(s) may be added following activation at the lead site.

Conditions

• Germ Cell Tumor
• Testicular Cancer

Interventions

Type	Name	Description
DRUG	Low-dose ASA	81 mg by mouth daily for 26 weeks

Timeline

• Start date: 2025-08-28
• Primary completion: 2029-08-01
• Completion: 2031-01-01
• First posted: 2025-03-10
• Last updated: 2026-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study