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Folate Analog

Arfolitixorin for Colorectal Cancer (AGENT Trial)

Phase 3
Waitlist Available
Led By Josep Tabernero, Prof.
Research Sponsored by Isofol Medical AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Colorectal adenocarcinoma verified by biopsy.
Availability of biopsy material, from the primary tumor or metastasis, allowing for analysis of tumor gene expression.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease progression, an average of ten months
Awards & highlights

AGENT Trial Summary

This trial is testing a new drug to see if it's better than the current standard of care for treating advanced colorectal cancer.

Eligible Conditions
  • Colorectal Cancer

AGENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have metastatic colorectal cancer that is non-resectable.
Select...
You are male or female, at least 18 years of age.

AGENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression, an average of ten months
This trial's timeline: 3 weeks for screening, Varies for treatment, and until disease progression, an average of ten months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Secondary outcome measures
Duration of Response
Progression Free Survival

Side effects data

From 2022 Phase 3 trial • 490 Patients • NCT03750786
52%
Nausea
47%
Diarrhea
43%
Fatigue
30%
Peripheral Sensory Neuropathy
27%
Constipation
27%
Neuropathy Peripheral
26%
Stomatitis
26%
Epistaxis
26%
Neutrophil Count Decreased
25%
Decreased Appetite
25%
Hypertension
23%
Vomiting
21%
Mucosal Inflammation
21%
Neutropenia
21%
Abdominal Pain
21%
Anemia
18%
Paresthesia
18%
Asthenia
16%
Pyrexia
16%
Dysgeusia
15%
Platelet Count Decreased
13%
Dysesthesia
13%
Alopecia
12%
Palmar-Plantar Erythrodysesthesia Syndrome
12%
Thrombocytopenia
12%
Hypokalaemia
11%
White Blood Cell Count Decreased
11%
Back Pain
11%
Urinary Tract Infection
10%
Headache
10%
Dyspepsia
9%
Neurotoxicity
9%
Dysphonia
9%
Dry Skin
8%
Dizziness
8%
Weight Decreased
8%
Pulmonary Embolism
8%
Hypoaesthesia
8%
Insomnia
7%
Hyperglycaemia
7%
Gamma-glutamyltransferase Increased
7%
Polyneuropathy
6%
Hiccups
6%
Abdominal Pain Upper
6%
Blood Alkaline Phosphatase Increased
5%
Alanine Aminotransferase Increased
5%
Arthralgia
5%
Pain in Extremity
5%
Aspartate Aminotransferase Increased
5%
Malaise
5%
Rash
5%
Proteinuria
5%
Gastroesophageal Reflux Disease
5%
Depression
4%
Intestinal Obstruction
4%
Cough
3%
Oedema Peripheral
3%
Dyspnoea
2%
Large Intestinal Obstruction
2%
Febrile Neutropenia
2%
Small Intestinal Obstruction
1%
Cholangitis
1%
Large Intestine Perforation
1%
Rectal Hemorrhage
1%
Device Related Infection
1%
Sepsis
1%
Urosepsis
1%
General Physical Health Deterioration
1%
Urinary Retention
1%
Acute Kidney Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group B
Group A

AGENT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group AExperimental Treatment1 Intervention
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Group II: Group BActive Control1 Intervention
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arfolitixorin
2018
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

Isofol Medical ABLead Sponsor
7 Previous Clinical Trials
358 Total Patients Enrolled
Josep Tabernero, Prof.Principal InvestigatorVall d'Hebron Institute of Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Arfolitixorin have any dangerous side effects?

"Arfolitixorin falls into Phase 3 of clinical trials, meaning that there is already some data supporting its efficacy and multiple rounds of tests affirming its safety. Consequently, our team rates Arfolitixorin's safety as a 3."

Answered by AI

What conditions does Arfolitixorin typically help alleviate?

"Arfolitixorin is most effective in combating methotrexate toxicity. Additionally, this medication can help treat normochromic anemia, advanced esophageal cancers, and folate deficiencies."

Answered by AI

Are there any geographic restrictions to this research study?

"Out of the 28 participating clinics, this trial is currently recruiting patients. A few locations where these medical centres can be found are Brampton, San Antonio and Gatineau. If you wish to enroll in the study, try and select a clinic that is close to your residence to limit travel."

Answered by AI

Yes, what other scientific investigations have included Arfolitixorin?

"Right now, there are 279 clinical trials being conducted for Arfolitixorin. 86 of those live clinical trials are in Phase 3. The majority of studies for Arfolitixorin are based in Melbourne, Victoria, but there are 16136 total locations running trials globally."

Answered by AI

Who else is applying?

What state do they live in?
Quebec
How old are they?
18 - 65
What site did they apply to?
840-24 - Banner Gateway Medical Center
124-02 - Hôpital de la Cité-de-la-Santé
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~78 spots leftby Mar 2025