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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
E7090 tablets orally.
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.
Time frame: 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)
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.
Time frame: 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 6 years 2 months)
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.
Time frame: 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 6 years 2 months)
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Tsinghua Chang Gung Memorial Hospital
Beijing, Beijing Municipality, China
Beijing Youan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijng Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical University Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong, China
...and 46 more locations
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.
Time frame: from the date of first study dose to the date of first documentation of CR or PR (up to approximately 6 years 2 months)
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.
Time frame: From the date of first dose to the date of death from any cause (up to approximately 6 years 2 months)
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.
Time frame: 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)
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.
Time frame: 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)