Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®) (NCT03414489) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)
Plain-language summary
This is an expanded access program (EAP) for eligible participants who do not qualify for participation in, or who are otherwise unable to access, the ongoing clinical trial ABC-108. This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of cholangiocarcinoma (CCA) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. An oncologist must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of cholangiocarcinoma
. Ineligible to participate in the ABC294640 clinical trial for the treatment of cholangiocarcinoma or geographically inaccessible to the trial.
. Judged by the treating oncologist to be medically suitable for treatment with ABC294640
. Willing and able to provide written, signed informed consent
. Approval by RedHill of the treating oncologist's clinical trial experience for the purpose of making ABC294640 available
. Regulatory approval by the appropriate jurisdiction
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this expanded access program for ABC294640 (Yeliva) is no longer available, can you tell me whether there are any other active clinical trials studying this same drug, or similar drugs targeting the same pathway, that might be worth looking into for my type of cholangiocarcinoma?
2Given that this program was specifically for non-resectable or advanced cholangiocarcinoma, what are the current standard-of-care treatment options you would recommend for my specific situation — intrahepatic, extrahepatic, or perihilar — now that this access route is closed?
3Because this was an expanded access program rather than a standard phase trial, what does that tell us about how much safety and effectiveness data was collected on ABC294640, and is any of that information relevant to decisions about my care?
4Are there other expanded access programs or compassionate use options currently open for advanced cholangiocarcinoma that I should know about, in case standard treatments aren't working well enough?
5Since my cholangiocarcinoma may have specific molecular or genetic features, is tumor genetic testing something we should do now so we can better match me to any future trials or targeted therapies that become available?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.