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Clinical Trials List

Protocol Number42756493CAN2002
NCT Number(ClinicalTrials.gov Identfier)NCT04083976
Completed

2019-11-01 - 2024-05-13

Phase II

Not yet recruiting2

Recruiting5

Terminated6

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Health Research Institutes

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴冠銘 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tai-Jan Chiu Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 饒坤銘 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ming-Feng Hou Division of General Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yi-Ping Hung Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

  • Yee Chao Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator YI-CHUN LIU Division of Radiation Therapy
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Advanced Solid Tumors

Objectives

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) mutations and gene fusions. Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified to have alterations in the FGFR pathway. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participants has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is defined as 4 years from enrollment of last participant into study or last follow-up visit of last patient, whichever occurs first.

Test Drug

Erdafitinib

Active Ingredient

Erdafitinib

Dosage Form

tablet

Dosage

3, 4, 5

Endpoints

Primary Outcome Measures :

Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC) [ Time Frame: Up to 6 Years ]
ORR as assessed by IRC is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR).

Inclution Criteria

Inclusion Criteria:

Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
Measurable disease
Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting
Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening

Exclusion Criteria

Exclusion Criteria:

Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or greater than or equal to (>=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib
The presence of FGFR gatekeeper and resistance mutations
Histologic demonstration of urothelial carcinoma
Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, and BRAF V600E
Active malignancies other than for disease requiring therapy

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    280 participants

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