Phase
Condition
Esophageal Disorders
Digestive System Neoplasms
Liver Cancer
Treatment
Erdafitinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pathologically or cytologically confirmed, advanced or refractory tumors (there areno restriction on the total number of lines of prior therapies, but participantshould have received at least 1 line of anti-cancer therapy [as per local standardof care]): Squamous and non-squamous non-small-cell lung cancer (NSCLC), esophagealcancer, urothelial cancer and cholangiocarcinoma
Participants must meet the following molecular eligibility criteria (diagnosed at acentral or local laboratory using either a tumor tissue based assay, which mustindicate: at least one of following): a) fibroblast growth factor receptor (FGFR)gene translocations b) FGFR gene mutations c) Participants with evidence of FGFRpathway activation or other potential target/pathway inhibited by erdafitinib mayalso be considered and allowed for enrollment if supported by emerging biomarkerdata.
The presence of measurable disease according to the RECIST, Version 1.1 Criteria,and documented disease progression as defined by RECIST (Version 1.1) at baseline
Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
Female participants (of child bearing potential and sexually active) and maleparticipants (with a partner of child bearing potential) must use medicallyacceptable methods of birth control. Male participants must use highly effectivebirth control measurements when sexually active and must not donate sperm
Adequate bone marrow, liver, and renal function within the 14 days prior to Day 1 ofCycle 1 up until pre-dose of Cycle 1
Exclusion
Exclusion Criteria:
Chemotherapy, targeted therapies, immunotherapy, or treatment with aninvestigational anticancer agent within 2 weeks or at least 5 half-lives of the drugwhichever is longer up to a maximum of 4 weeks before the first administration ofstudy drug. Localized palliative radiation therapy (but should not include radiationto target lesions) and ongoing luteinizing hormone-releasing hormone (LHRH)agonists, bisphosphonates and denosumab, are permitted
Participants with persistent phosphate greater than (>) upper limit of normal (ULN)during Screening (within 14 days prior to Day 1 of Cycle 1 up until pre-dose ofCycle 1) and despite medical management of phosphate levels
Participants taking medications known to have a significant risk of causing QTcprolongation and Torsades de Pointes. Participants who have discontinued any ofthese medications must have a wash-out period of at least 5 days or at least 5half-lives of the drug (whichever is longer) prior to the first dose of study drug
Left ventricular ejection fraction (LVEF) less than (<) 50% as assessed byechocardiography (or multi-gated acquisition [MUGA]) performed at Screening
Uncontrolled inter-current illness including, but not limited to, poorly controlledhypertension or diabetes, ongoing active infection requiring antibiotics,psychiatric illness, or at risk of gastrointestinal perforation as perinvestigators' assessment
Received prior selective FGFR inhibitor treatment or RET inhibitor treatment,respectively according to the biomarker prescreening result, or if the participanthas known allergies, hypersensitivity, or intolerance to Erdafitinib or itsexcipients
Any corneal or retinal abnormality likely to increase risk of eye toxicity
Study Design
Study Description
Connect with a study center
Beijing,
ChinaSite Not Available
The Third Xiangya Hospital, Central South University
Chang Sha, 410013
ChinaSite Not Available
empty
Changchun,
ChinaSite Not Available
Hunan Cancer hospital
Changsha, 410013
ChinaSite Not Available
West China Hospital Sichuan University
Chengdu, 610041
ChinaSite Not Available
Chongqing Cancer hospital
Chongqing, 400030
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou, 430030
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University College of Medicine
Hang Zhou, 310003
ChinaSite Not Available
Harbin,
ChinaSite Not Available
Anhui Provincial Cancer Hospital
Heifei, 233004
ChinaSite Not Available
Nanjing,
ChinaSite Not Available
Shanghai Tenth People's Hospital
Shanghai, 200072
ChinaSite Not Available
Liaoning Cancer Hospital & Institute
Shenyang, 110000
ChinaSite Not Available
empty
Tianjin,
ChinaSite Not Available
Weifang People's Hospital
Weifang, 261000
ChinaSite Not Available
The first affiliated hospital of xiamen university
Xia Men, 361003
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zheng Zhou, 450052
ChinaSite Not Available
Seoul,
Korea, Republic ofSite Not Available
Kaohsiung,
TaiwanSite Not Available
China Medical University Hospital
Taichung, 40447
TaiwanSite Not Available
Tainan,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available

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