NCT03542877

Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer

An Open-Label, Single-Arm, Two-Stage Phase II Study Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Academic Thoracic Oncology Medical Investigators Consortium · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to use Cabozantinib to treat those with Metastatic Colorectal Cancer who have not previously responded to treatment.

Detailed description

This is a phase II clinical trial that seeks to use Cabozantinib to treat those with Metastatic Colorectal Cancer who have not previously responded to treatment. This study is a two stage study that will first measure (up to) 16 patients' progression free survival (PFS). Stage two will, again, measure PFS, but in a population (up to) 28 patients.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Oral Tablet: Cabozantinib	Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-10-19
• Completion: 2022-03-07
• First posted: 2018-05-31
• Last updated: 2022-07-15
• Results posted: 2022-06-02

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study