NCT02654639

Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer

An Open-Label, Multi-center, Phase 2 Study of Switch Maintenance With TAS-102 Plus Bevacizumab Following Oxaliplatin or Irinotecan-Based Fluoropyrimidine-Containing Induction Chemotherapy in Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

Detailed description

Study Drug: TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab Dosing Details: Starting dose of TAS-102 is 35 mg/m2 administered orally twice daily, after meals, for 5 days a week with 2 days rest for 14 days, followed by 14 days rest (1 treatment cycle). Bevacizumab 5 mg/kg intravenously every 14 days. The treatment cycle repeats every 28 days. Patients may take TAS-102 plus bevacizumab until they exhibit progression of disease, withdraw consent, or experience unacceptable toxicity.This is a single arm study. All patients receive the same study treatment.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TAS-102	TAS-102 Twice a day by mouth day 1-5 and 8-12
DRUG	Bevacizumab	Bevacizumab by intravenous infusion once every 14 days

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-01-13
• Last updated: 2018-08-07
• Results posted: 2018-08-07

Locations

1 site across 1 country: United States