Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer (ALEXANDRIA)
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|ClinicalTrials.gov Identifier: NCT02654639|
Recruitment Status : Terminated (Principal investigator left the institution)
First Posted : January 13, 2016
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: TAS-102 Drug: Bevacizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Experimental: TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab by intravenous infusion once every 14 days
- Length of Progression-Free Survival [ Time Frame: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years. ]Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654639
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Mohamed Salem, MD||Georgetown University|