Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

Phase

N/A

Condition

Biliary Tract Cancer

Liver Cancer

Abdominal Cancer

Treatment

ABC294640

Clinical Study ID

NCT03414489

ABC-108-EA

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosis of cholangiocarcinoma
Ineligible to participate in the ABC294640 clinical trial for the treatment ofcholangiocarcinoma or geographically inaccessible to the trial.
Judged by the treating oncologist to be medically suitable for treatment withABC294640
Willing and able to provide written, signed informed consent
Approval by RedHill of the treating oncologist's clinical trial experience for thepurpose of making ABC294640 available
Regulatory approval by the appropriate jurisdiction

Exclusion

Exclusion Criteria:

Any medical condition that may cause treatment with ABC294640 to be potentiallyharmful as judged by RedHill

Study Design

ABC294640