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临床试验/NCT03414489
NCT03414489No Longer Available不适用

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

RedHill Biopharma Limited0 个研究点开始时间: 2018年1月30日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
No Longer Available

研究概览

简要总结

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.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究者

申办方类型
Industry
责任方
Sponsor

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