Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer (ALEXANDRIA)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Progression-Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2016|
|Estimated Study Completion Date:||February 2020|
|Estimated Primary Completion Date:||October 2019 (Final data collection date for primary outcome measure)|
Experimental: TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
Drug: TAS-102 and Bevacizumab
TAS-102 Twice a day by mouth day 1-5 and 8-12 and Bevacizumab by intravenous infusion once every 14 days
TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02654639
|Contact: Karen Vogel, RNfirstname.lastname@example.org|
|Contact: Holly DiFebo, BSNemail@example.com|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Mohamed Salem, MD||Georgetown University|