NCT01661972

Phase I/II Study of Capecitabine Plus Aflibercept to Treat Metastatic Colorectal Cancer

X-TRAP: Phase I/II Study of Capecitabine Plus Aflibercept in Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: John Strickler, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Primary Phase I objectives are to determine the recommended phase II dose for the capecitabine and aflibercept doublet combination; and to describe any dose limiting and non-dose limiting toxicities. The Phase II Primary objective is to determine progression free survival associated with this regimen. The Phase II secondary objectives are to determine response rate associated with this regimen; to determine overall survival associated with this regimen; and to explore any correlation of clinical outcome with baseline and on treatment changes in blood-based angiogenesis biomarkers. This open-label, non-randomized phase I/II trial is designed to assess the safety, tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic colorectal cancer.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine and aflibercept	Capecitabine given on days 1-14 and off days 15-21. Dose: Phase 1 cohort 1 850mg/m2 Phase 1 cohort 2 1000mg/m2, Phase 2 RPTD. Aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks. Both agents will be administered on a 21-day cycle.

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-06-12
• Completion: 2016-06-12
• First posted: 2012-08-10
• Last updated: 2018-10-29
• Results posted: 2017-07-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study