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

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ClinicalTrials.gov Identifier: NCT03414489
Expanded Access Status : Available
First Posted : January 30, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

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.

Condition or disease Intervention/treatment
Cholangiocarcinoma Cholangiocarcinoma Non-resectable Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Intrahepatic Drug: ABC294640

Study Type : Expanded Access
Expanded Access Type : Individual Patients
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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414489


Contacts
Contact: Mark L Levitt, MD, PhD +972-3-541-3131 mark@redhillbio.com
Contact: Vered Katz Ben-Yair, MSc 347-414-4462 vered@redhillbio.com

Sponsors and Collaborators
RedHill Biopharma Limited

Publications of Results:
Other Publications:
Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT03414489     History of Changes
Other Study ID Numbers: ABC-108-EA
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Keywords provided by RedHill Biopharma Limited:
Clinical Trial, Phase II
Multicenter Trials
Clinical Study
Clinical Trials, Non-Randomized
Oral capsule
Single arm
Anti-cancer
Anti-inflammatory
ABC294640
Expanded Access Program
Compassionate Use
Special Access Program
Yeliva ®
opaganib

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms