Cholangiocarcinoma is a cancer that begins in the bile duct—a small tube that leads from the liver and gallbladder, through the pancreas, and connects to the small intestine. The bile duct carries bile, a fluid made by the liver to help with digestion. Doctors classify cholangiocarcinoma according to the location of the initial tumor: either within the liver (intrahepatic) or, more commonly, outside the liver (extrahepatic).1
If caught early, surgery can remove the tumor.1 Radiation treatment can kill cancer cells by directing small doses of radiation to the tumor region.1 However, cholangiocarcinoma often spreads to other areas within and outside the liver.1,2 Once the disease reaches this advanced stage, doctors may prescribe chemotherapy to kill the cancer cells, but this may also kill healthy cells throughout the body.1,2
Cholangiocarcinoma begins in the bile duct, but each patient's cancer is fundamentally different. A unique combination of genetic changes (mutations) contributes to the cancer cells' out-of-control growth.1,2 A new wave of therapies called targeted therapies are being developed that specifically target only those mutations present in a patient's cancer.2
AG-120: Investigational medication for IDH1-mutated advanced cholangiocarcinoma
AG-120, developed by Agios, is a targeted therapy that targets cancer cells with a mutation in a gene called IDH1. Among patients with cholangiocarcinoma, 13%-15% may have an IDH1 mutation in their tumor.3,4
The ClarIDHy clinical trial is a Phase 3 trial testing the safety and efficacy of AG-120 in patients with IDH1-mutated advanced cholangiocarcinoma.
The safety and efficacy of AG-120 have not been established. There is no guarantee that AG-120 will receive health authority approval or become commercially available for the use being investigated.
Genomic testing in cholangiocarcinoma
Genomic testing can identify the unique combination of mutations present in a patient's cancer, including mutations in the IDH1 gene. This information can help you and your doctor determine if you are eligible for the ClarIDHy clinical trial.
Is the ClarIDHy clinical trial right for you or your loved one?
To be eligible for the ClarIDHy clinical trial, patients must meet certain criteria, including5:
- Be at least 18 years old
- Have advanced cholangiocarcinoma that cannot be surgically removed
- Have a mutation in IDH1 (genomic testing will be provided by the clinical trial)
- Have been treated with cancer medication, but your disease has grown or spread
Talk to your doctor to determine your eligibility for the ClarIDHy clinical trial. For additional eligibility criteria, and to find a ClarIDHy clinical trial site near you, please visit ClinicalTrials.gov
Ask your doctor if you're eligible for the ClarIDHy clinical trial.
Clinical studies FAQs
- The ClarIDHy clinical trial is testing the safety and efficacy of AG-120 in patients with IDH1-mutated advanced cholangiocarcinoma.
- The purpose of the ClarIDHy clinical trial is to learn if AG-120 can slow the growth or spread of IDH1-mutated advanced cholangiocarcinoma.
- To be eligible for the ClarIDHy clinical trial, you must meet certain criteria.5 These include: being at least 18 years old, having IDH1-mutated advanced cholangiocarcinoma, and being previously treated with cancer medication, but your disease has continued to grow or spread. Talk to your doctor about your eligibility for the ClarIDHy clinical trial.
- The ClarIDHy clinical trial will provide IDH1 testing for all patients who meet other eligibility requirements.5 Talk to your doctor about your eligibility for the ClarIDHy clinical trial.
- Only patients with an IDH1 mutation are eligible for the ClarIDHy clinical trial.
- The ClarIDHy clinical trial is being conducted in several U.S. cities. Once your doctor determines if you are eligible for the ClarIDHy clinical trial, you will receive further information about participating sites near you.
- Blechacz B. Cholangiocarcinoma: Current Knowledge and New Developments. Gut Liver. 2016;1-14. [Epub ahead of print]
- Chong DQ, Zhu AX. The landscape of targeted therapies for cholangiocarcinoma: current status and emerging targets. Oncotarget. 2016;7(29):46750-46767.
- Borger DR, Tanabe KK, Fan KC, et al. Frequent mutation of isocitrate dehydrogenase (IDH)1 and IDH2 in cholangiocarcinoma identified through broad-based tumor genotyping. Oncologist. 2012;17(1):72-79.
- Kipp BR, Voss JS, Kerr SE, et al. Isocitrate dehydrogenase 1 and 2 mutations in cholangiocarcinoma. Hum Pathol. 2012;43(10):1552-1558.
- Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy). ClinicalTrials.gov. U.S. National Institutes of Health. https://www.clinicaltrials.gov/ct2/show/study/NCT02989857. Accessed December 14, 2016.