Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable… (NCT03230318) | Clinical Trial Compass
CompletedPhase 2
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
United States148 participantsStarted 2017-09-28
Plain-language summary
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent granted prior to initiation of any study-specific procedures
✓. 18 years of age or older
✓. Histologically or cytologically confirmed locally advanced, inoperable, or metastatic iCCA or mixed histology tumors
✓. Substudy 1:
✓. Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression
✓. Measurable disease by RECIST version 1.1 criteria
✓. ECOG performance status ≤ 1
✓. Adequate organ functions as indicated by the following laboratory values (based on screening visit values from the central laboratory).
Exclusion criteria
✕. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:
✕. Major surgery, locoregional therapy, or radiation therapy within four weeks of the first dose of derazantinib
✕. Clinically unstable central nervous system (CNS) metastases (to be eligible, subjects must had stable disease ≥ 3 months, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and/or had CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications)
✕. Evidence of clinically significant corneal or retinal disorder which was likely to increase the risk of eye toxicity, including but not limited to bullous/band keratopathy, keratoconjunctivitis (unless keratoconjunctivitis sicca), corneal abrasion, inflammation/ulceration, confirmed by ophthalmologic examination.
✕. Uncontrolled or active hepatobiliary disorders, untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, biloma or abscess (to be eligible, the subjects had to be treated and disorders/complications should had been resolved within 2 weeks prior to the first dose of derazantinib)