A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion

Korábbi kezelés

• 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.
• Concomitant active infection requiring systemic treatment (except hepatitis B or C virus-infected participants who are under anti-viral treatment).
• Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v4.03), except for alopecia, infertility and the adverse events listed in inclusion criteria.
• Participants with prior therapy targeting FGFR2.
• Participants who need the use of drugs or foods that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A4 during study treatment (there must be a time interval of >= 7 days since the final use of these drugs or foods by the start of study treatment).

Más betegség

• Participants who test positive for human immunodeficiency virus (HIV antibody) at Screening 2.

Életkor

• 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)

Egyéb

• Child-Pugh score B or C.
• Moderate or severe ascites extending from the pelvis to the liver surface.

• 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)
  • Prior adjuvant chemotherapy is allowed if relapse was within 6 months after last administration.
• 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.
• Participants with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG).
• Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug.
• Washout period required from the end of prior treatment to the start of E7090 administration will be as follows
  • Antibody and other investigational drugs : >=4 weeks
  • Prior chemotherapy (except small-molecule targeted therapy), surgical therapy, radiation therapy：>=3 weeks
  • Endocrine therapy, immunotherapy, small-molecule targeted therapy: >=2 weeks