A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma

Last updated: April 24, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

Esophageal Disorders

Digestive System Neoplasms

Liver Cancer

Treatment

Erdafitinib

Clinical Study ID

NCT02699606
CR108120
42756493LUC2001
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to evaluate objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC), urothelial cancer, esophageal cancer and cholangiocarcinoma.

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

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Erdafitinib
Phase: 2
Study Start date:
July 08, 2016
Estimated Completion Date:
March 15, 2024

Study Description

This is an open-label (all people know the identity of the intervention), multicenter, phase 2 study to evaluate the clinical efficacy, safety and pharmacokinetics of erdafitinib in Asian participants with advanced NSCLC, urothelial cancer, esophageal cancer and cholangiocarcinoma.

Connect with a study center

  • Beijing,
    China

    Site Not Available

  • The Third Xiangya Hospital, Central South University

    Chang Sha, 410013
    China

    Site Not Available

  • empty

    Changchun,
    China

    Site Not Available

  • Hunan Cancer hospital

    Changsha, 410013
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • Chongqing Cancer hospital

    Chongqing, 400030
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 430030
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University College of Medicine

    Hang Zhou, 310003
    China

    Site Not Available

  • Harbin,
    China

    Site Not Available

  • Anhui Provincial Cancer Hospital

    Heifei, 233004
    China

    Site Not Available

  • Nanjing,
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai, 200072
    China

    Site Not Available

  • Liaoning Cancer Hospital & Institute

    Shenyang, 110000
    China

    Site Not Available

  • empty

    Tianjin,
    China

    Site Not Available

  • Weifang People's Hospital

    Weifang, 261000
    China

    Site Not Available

  • The first affiliated hospital of xiamen university

    Xia Men, 361003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zheng Zhou, 450052
    China

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

  • Kaohsiung,
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • Tainan,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

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