A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer (AGENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03750786|
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colo-rectal Cancer||Drug: Arfolitixorin Drug: Leucovorin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer|
|Actual Study Start Date :||December 18, 2018|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||January 31, 2023|
Experimental: Group A
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
Active Comparator: Group B
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
- Overall response rate [ Time Frame: Until disease progression, an average of ten months ]Best ORR, defined as the best response recorded from the start of the study treatment until the end of treatment.
- Progression free survival [ Time Frame: Until disease progression, an average of ten months ]PFS, defined as the time from randomization to first occurrence of tumor progression based on CT-scans/MRIs.
- Duration of response [ Time Frame: Until disease progression, an average of ten months ]The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
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): NCT03750786
|Contact: Roger Tell, MD, PhD||+46 (0) 760 293 firstname.lastname@example.org|
|Principal Investigator:||Josep Tabernero, Prof.||Vall d'Hebron Institute of Oncology|