Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)
Sponsor: RedHill Biopharma Limited
ClinicalTrials ID:NCT03414489
This expanded access program provides ABC294640 to cholangiocarcinoma patients ineligible for the ABC-108 trial. Eligibility requires a diagnosis, oncologist approval, informed consent, and regulatory clearance. The drug, ABC294640, is offered where local regulations permit, with oncologist oversight ensuring suitability for treatment.
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Program Overview
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.
Eligibility Criteria
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
Exclusion Criteria
- Any medical condition that may cause treatment with ABC294640 to be potentially harmful as judged by RedHill
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