A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With… (NCT04238715) | Clinical Trial Compass
CompletedPhase 2
A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion
China63 participantsStarted 2020-01-22
Plain-language summary
The primary purpose of the study is to assess the objective response rate (ORR) of E7090 by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 based on independent imaging review (IIR) in participants with unresectable cholangiocarcinoma with FGFR2 gene fusion who failed gemcitabine-based combination chemotherapy.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Participants with a histologically or cytologically diagnosis of intrahepatic or perihilar cholangiocarcinoma who agree to provide archival tumor sample or residual biopsy sample, or agree with tumor biopsy.
✓. Participants who have confirmed FGFR2 gene fusion of tumor by fluorescence in situ hybridization (FISH) in central laboratory. FGFR2 gene fusion confirmed by the same FISH assay in another test/study will be discussed with the sponsor and agreed on a case by case basis.
✓. Participants with surgically unresectable or advanced/metastatic disease who have received at least one prior chemotherapy including gemcitabine-based combination chemotherapy (example: gemcitabine and cisplatin)
✓. Measurable disease meeting the following criteria:
✓. At least 1 lesion of \>=1.0 centimeter (cm) in the longest diameter for a non-lymph node or \>=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI).
✓. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
✓. Corrected serum calcium less than or equal to (\<=) upper limit of normal (ULN).
✓. Phosphate \<=ULN.
Exclusion criteria
✕. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
What they're measuring
1
ORR
Timeframe: From first dose of study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years 2 months)
✕. Concomitant active infection requiring systemic treatment (except hepatitis B or C virus-infected participants who are under anti-viral treatment).
✕. Participants who test positive for human immunodeficiency virus (HIV antibody) at Screening 2.
✕. Child-Pugh score B or C.
✕. Moderate or severe ascites extending from the pelvis to the liver surface.
✕. Following ocular disorders
✕. Current evidence of Grade 2 or higher corneal disorder
✕. Current evidence of active macula disorder (example: age-related macular degeneration, central serous chorioretinal disease)