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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04238715
Other study ID # E7090-J000-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 22, 2020
Est. completion date September 1, 2024

Study information

Verified date March 2023
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 63
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Measurable disease meeting the following criteria: 1. 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). 2. 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. 5. Corrected serum calcium less than or equal to (<=) upper limit of normal (ULN). 6. Phosphate <=ULN. 7. Participants with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG). 8. Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug. 9. Washout period required from the end of prior treatment to the start of E7090 administration will be as follows 1. Antibody and other investigational drugs : >=4 weeks 2. Prior chemotherapy (except small-molecule targeted therapy), surgical therapy, radiation therapy:>=3 weeks 3. Endocrine therapy, immunotherapy, small-molecule targeted therapy: >=2 weeks Exclusion Criteria: 1. 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. 2. Concomitant active infection requiring systemic treatment (except hepatitis B or C virus-infected participants who are under anti-viral treatment). 3. Participants who test positive for human immunodeficiency virus (HIV antibody) at Screening 2. 4. Child-Pugh score B or C. 5. Moderate or severe ascites extending from the pelvis to the liver surface. 6. Following ocular disorders 1. Current evidence of Grade 2 or higher corneal disorder 2. Current evidence of active macula disorder (example: age-related macular degeneration, central serous chorioretinal disease) 7. 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. 8. Participants with prior therapy targeting FGFR2. 9. 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
E7090
E7090 tablets orally.

Locations

Country Name City State
China Affiliated Hospital of Hebei University Baoding Hebei
China Beijing Tsinghua Chang Gung Memorial Hospital Beijing Beijing
China Beijing Youan Hospital Affiliated to Capital Medical University Beijing Beijing
China Beijng Cancer Hospital Beijing Beijing
China Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing
China Peking Union Medical University Hospital Beijing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China Jilin Cancer Hospital Changchun Jilin
China Hunan provincial people's hospital Changsha Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital of Central South University Changsha Hunan
China West China Hospital of Sichuan University Chengdu Sichuan
China Fujian Provincial Hospital Fuzhou Fujian
China Guangdong Province Traditional Chinese Medical Hospital Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen Univeristy Guangzhou Guangdong
China The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang
China The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
China Affilicataed Cancer Hospital of Harbin Medical University Harbin Heilongjiang
China Anhui Provincial Hospital Hefei Anhui
China Shandong Cancer Hospital Jinan Shandong
China Jiangsu Province Hospital Nanjing Jiangsu
China Nantong Tumor Hospital Nantong Jiangsu
China Ningbo First Hospital Ningbo Zhejiang
China Fudan University Shanghai Cancer Center Shanghai Shanghai
China Zhongshan Hospital Fudan University Shanghai Shanghai
China Peking University Shenzhen Hospital Shenzhen Guangdong
China The First Affiliated Hospital of Soochow Suzhou Jiangsu
China Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China The First Affiliated Hospital of Xiamen University Xiamen Fujian
China Henan Cancer Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Japan Eisai Trial Site 5 Bunkyo-ku Tokyo
Japan Eisai Trial Site 18 Chiba
Japan Eisai Trial Site 4 Chuo-ku Tokyo
Japan Eisai Trial Site 15 Fukuoka
Japan Eisai Trial Site 13 Hirakata Osaka
Japan Eisai Trial Site 20 Kagoshima
Japan Eisai Trial Site 8 Kanazawa Ishikawa
Japan Eisai Trial Site 16 Kashiwa Chiba
Japan Eisai Trial Site 19 Kochi
Japan Eisai Trial Site 6 Koto-ku Tokyo
Japan Eisai Trial Site 12 Kyoto
Japan Eisai Trial Site 11 Matsuyama Ehime
Japan Eisai Trial Site 14 Matsuyama Ehime
Japan Eisai Trial Site 3 Mitaka Tokyo
Japan Eisai Trial Site 10 Nagoya Aichi
Japan Eisai Trial Site 21 Niigata
Japan Eisai Trial Site 2 Sapporo Hokkaido
Japan Eisai Trial Site 22 Sendai Miyagi
Japan Eisai Trial Site 17 Suita Osaka
Japan Eisai Trial Site 9 Sunto-gun Shizuoka
Japan Eisai Trial Site 23 Tsu Mie
Japan Eisai Trial Site 1 Ube-Shi Yamaguchi
Japan Eisai Trial Site 24 Wakayama
Japan Eisai Trial Site 7 Yokohama Kanagawa

Sponsors (1)

Lead Sponsor Collaborator
Eisai Co., Ltd.

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR The ORR will be assessed by IIR based on RECIST version 1.1. ORR is defined as a percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). CR: disappearance of all (targeted and non-target [NT]) lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline, associated to non-progressive disease (non-PD) response for (NT) lesions. 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 2 years 11 months)
Secondary Progression Free Survival (PFS) PFS will be assessed by IIR based on RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease (PD) or date of death from any cause, whichever occurs first. PD per RECIST 1.1 is defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. From the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first (up to approximately 2 years 11 months)
Secondary Duration of Response (DOR) DOR will be assessed by IIR based on RECIST version 1.1. DOR is defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions. From the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first (up to approximately 2 years 11 months)
Secondary Time to Response (TTR) TTR will be assessed by IIR based on RECIST version 1.1. TTR is defined as the time from the date of first study dose to the date of first documentation of CR or PR. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions. from the date of first study dose to the date of first documentation of CR or PR (up to approximately 2 years 11 months)
Secondary Overall Survival (OS) OS is defined as the time from the date of first dose to the date of death from any cause. For the participants who are alive or unknown, OS is censored as the date of last known alive date. From the date of first dose to the date of death from any cause (up to approximately 2 years 11 months)
Secondary Disease Control Rate (DCR) DCR will be assessed by IIR based on RECIST version 1.1. DCR is defined as a percentage of participants with BOR of CR, PR or stable disease (SD). The BOR of SD has to be observed greater than or equal to (>=) 7 weeks from the date of first study dose. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions. 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 2 years 11 months)
Secondary Clinical Benefit Rate (CBR) CBR will be assessed by IIR based on RECIST version 1.1. CBR is defined as a percentage of participants with BOR of CR, PR or durable SD (dSD) (duration of SD >=23 weeks). CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions. 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 2 years 11 months)
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