TerminatedPhase 2

Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements

Stopped: slow recruitment

Germany2 participantsStarted 2022-11-11

Plain-language summary

The aim of this phase II study is to determine whether pemigatinib is clinically efficious after curative local therapy such as surgery/ SBRT or ablation in iCCA patients harboring FGFR2 fusion/rearrangement and to assess the safety profile to support the continuation of the concept in a large, randomized trial for further development.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Absolute number of neutrophils ≥ 1.5 x 109/L
✓. Platelets ≥ 100 x 109/L
✓. Hemoglobin ≥ 9 g/dL (5.58 mmol/L)
✓. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
✓. AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN without existing liver metastases, or ≤ 5 x ULN in the presence of liver metastases; AP ≤ 5 x ULN.
✓. CD4 count is ≥350 cells/uL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications
✓. Probable long-term survival with HIV if cancer were not present
✓. Stable on a highly active antiretroviral therapy (HAART) regimen for ≥4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study

What they're measuring

Objective response rate at time of progression

Timeframe: through study completion, approx. 3 years

Trial details

NCT IDNCT05565794

SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-27

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