A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion
Cholangiocarcinoma
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring E7090, Cholangiocarcinoma, Unresectable cholangiocarcinoma, Metastatic cholangiocarcinoma, Fibroblast Growth Factor Receptor 2 (FGFR2), FGFR2 gene fusion
Eligibility Criteria
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)
a. 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
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.
- 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)
- 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).
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical College
- Anhui Provincial Hospital
- Beijing Tsinghua Chang Gung Memorial Hospital
- Beijing Youan Hospital Affiliated to Capital Medical University
- Beijng Cancer Hospital
- Cancer Hospital Chinese Academy of Medical Sciences
- Peking Union Medical University Hospital
- Fujian Provincial Hospital
- The First Affiliated Hospital of Xiamen University
- Guangdong Province Traditional Chinese Medical Hospital
- The First Affiliated Hospital, Sun Yat-sen Univeristy
- Peking University Shenzhen Hospital
- Affiliated Hospital of Hebei University
- Affilicataed Cancer Hospital of Harbin Medical University
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
- Hunan provincial people's hospital
- The Third Xiangya Hospital of Central South University
- Xiangya Hospital of Central South University
- Jiangsu Province Hospital
- Nantong Tumor Hospital
- The First Affiliated Hospital of Soochow
- Jilin Cancer Hospital
- Shandong Cancer Hospital
- Fudan University Shanghai Cancer Center
- Zhongshan Hospital Fudan University
- West China Hospital of Sichuan University
- The First Affiliated Hospital, College of Medicine, Zhejiang University
- The Second Affiliated Hospital, Zhejiang University School of Medicine
- Ningbo First Hospital
- Eisai Trial Site 10
- Eisai Trial Site 16
- Eisai Trial Site 11
- Eisai Trial Site 14
- Eisai Trial Site 2
- Eisai Trial Site 8
- Eisai Trial Site 7
- Eisai Trial Site 23
- Eisai Trial Site 22
- Eisai Trial Site 13
- Eisai Trial Site 17
- Eisai Trial Site 9
- Eisai Trial Site 5
- Eisai Trial Site 4
- Eisai Trial Site 6
- Eisai Trial Site 3
- Eisai Trial Site 1
- Eisai Trial Site 18
- Eisai Trial Site 15
- Eisai Trial Site 20
- Eisai Trial Site 19
- Eisai Trial Site 12
- Eisai Trial Site 21
- Eisai Trial Site 24
Arms of the Study
Arm 1
Experimental
E7090 140 mg
Participants will receive E7090 140 mg (milligram), tablets orally once daily (QD), in 28-days treatment cycle until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination.