Ursodiol (** Actigall, Urso, Urso Forte (Generic: Ursodiol/Ursodeoxycholic acid) **)

Other Medications

EU Experimental ES Not available 1 Clinical Trials

Description

Ursodiol (also known as ursodeoxycholic acid) is a medication currently being studied in clinical trials, primarily for liver conditions. In the context of colorectal cancer, it has been investigated in combination with standard chemotherapy (like FOLFOX) and bevacizumab in a Phase 1 trial. This trial aimed to determine the safe dosage of ursodiol when added to this standard treatment regimen for advanced (Stage IV) colorectal cancer. The study also explored how ursodiol might affect metabolism (glucose and lipids) and whether these effects could be measured as biomarkers. It is important to note that ursodiol is not an approved treatment for colorectal cancer and is still under investigation for this purpose.

Mechanism of Action

Ursodiol is a bile acid. In the clinical trial context for colorectal cancer, it was given alongside standard chemotherapy (FOLFOX) and bevacizumab. The trial investigated whether ursodiol could activate a specific receptor in the body called the farnesoid X receptor (FXR). Activating FXR can influence glucose and lipid metabolism. Researchers were studying whether these metabolic changes might have an effect on the cancer or if they could be used as markers to track the drug's activity. The specific mechanism by which ursodiol might affect cancer cells, if at all, is not the primary focus of this trial, but rather its metabolic effects and safety when combined with standard CRC treatments.

Side Effects

The clinical trial (NCT00873275) was a Phase 1 dose-escalation study Meaning its primary goal was to find the safest dose of ursodiol when combined with standard chemotherapy (FOLFOX) and bevacizumab. Therefore The focus was on monitoring for side effects related to this combination. Specific side effects related to ursodiol itself when used in this context are still being evaluated. Common side effects of the standard chemotherapy (FOLFOX) and bevacizumab used in the trial include nausea Vomiting Diarrhea Fatigue Neuropathy (numbness/tingling) And changes in blood counts. The trial participants were closely monitored for toxicity to determine the maximum tolerated dose of ursodiol in this combination.

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT00873275 Phase 1
Completed
Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
United States

Quick Info

Brand Name** Actigall, Urso, Urso Forte (Generic: Ursodiol/Ursodeoxycholic acid) **
CategoryOther Medications
EU EMA StatusExperimental
ES Spain AccessNot available
Clinical Trials1
View Clinical Trials Back to Drug Glossary

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Medical Disclaimer

This information is for educational purposes only and should not replace professional medical advice. Always consult your healthcare team before making treatment decisions.