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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03414489
Expanded Access Status : Available
First Posted : January 30, 2018
Last Update Posted : November 29, 2018
Information provided by (Responsible Party):
RedHill Biopharma Limited

Tracking Information
First Submitted Date January 22, 2018
First Posted Date January 30, 2018
Last Update Posted Date November 29, 2018
Descriptive Information
Brief Title Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)
Official Title Expanded Access to ABC-108, A Phase IIA Study of ABC294640 in the Treatment of Patients With Advanced,Unresectable Intra-hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma
Brief 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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
  • Cholangiocarcinoma
  • Cholangiocarcinoma Non-resectable
  • Cholangiocarcinoma, Perihilar
  • Cholangiocarcinoma, Extrahepatic
  • Cholangiocarcinoma, Intrahepatic
Intervention Drug: ABC294640
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Any medical condition that may cause treatment with ABC294640 to be potentially harmful as judged by RedHill

Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contact: Mark L Levitt, MD, PhD +972-3-541-3131
Contact: Vered Katz Ben-Yair, MSc 347-414-4462
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03414489
Other Study ID Numbers ABC-108-EA
Responsible Party RedHill Biopharma Limited
Study Sponsor RedHill Biopharma Limited
Collaborators Not Provided
Investigators Not Provided
PRS Account RedHill Biopharma Limited
Verification Date November 2018