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Be Part of Research - Trial Details - Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Cholangiocarcinoma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2023 May 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.

Intervention Arm Group : Tinengotinib 8 mg QD;

Intervention Type : DRUG
Intervention Description : Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.

Intervention Arm Group : Tinengotinib 10 mg QD;

Intervention Type : DRUG
Intervention Description : For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.

Intervention Arm Group : Physician's Choice;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Marsden Hospital NHS
    London
  • UCG-1st floor central
    London
  • The Christie NHS Foundation Trust - Christie Hospital
    Manchester
  • Nottingham University Hospitals NHS Trust
    Nottingham


The study is sponsored by TransThera Sciences (Nanjing), Inc.




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Read full details for Trial ID: NCT05948475
Last updated 21 June 2024

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