NCT04786600

A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This randomized, phase 2 study will investigate the use of the Signatera ctDNA assay versus the standard scan-based approach to guide treatment in patients with metastatic colorectal cancer. The aim of this study will be to measure and compare the overall survival, progression-free survival, and best overall response while on study of patients whose treatment has been guided by these two approaches.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Signatera ctDNA assay	Subjects will be tested with the Signatera ctDNA assay every 2 weeks.
DRUG	pre-specified sequence of FDA-approved drugs and drug combinations	Subjects will receive treatment with a pre-specified sequence of FDA-approved drugs and drug combinations

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-03-19
• Completion: 2024-03-19
• First posted: 2021-03-08
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study