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Pemigatinib in Advanced/Metastatic Cholangiocarcinoma with FGFR2 Rearrangement
NCT04256980Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2020
- Primary completion
- Jan 2021
- Countries
- 1
- Sponsor
- Innovent Biologics
- Modality
- Fragment-Derived Small Molecules, Reversible Covalent Inhibitors, Bivalent/Multivalent Binders
- Drugs
- pemigatinib
- Conditions
- cholangiocarcinoma (CCA)
01
Overview
Phase 2, open-label, single-arm trial of pemigatinib in cholangiocarcinoma (CCA), sponsored by Innovent Biologics. Primary endpoint: Objective Response Rate up to 24 months. Started Mar 2020; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Pemigatinib Arm
Pemigatinib self-administered orally on a 2-week-on/1-week-off schedule.
03
Who it enrols
Adult patients with histologically confirmed advanced/metastatic or surgically unresectable cholangiocarcinoma with documented FGFR2 rearrangement who have failed at least 1 previous therapy and have ECOG PS 0-1.
04
Endpoints
Primary
Objective Response Rate
Secondary
Progression-Free Survival
Duration of Response
Disease Control Rate
Overall Survival
05
Results
Primary endpoints met
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