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

NCT02699606 | Completed Phase 2 DMC

• 2 other identifiers: CR10812042756493LUC2001
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Neoplasm

Keywords

Tumor; Fibroblast Growth Factor Receptor (FGFR); Non-Small Cell Lung Cancer (NSCLC); Erdafitinib; Urothelial Cancer; Esophageal Cancer; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) is defined as proportion of participants with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.

  From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years)

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years)

• Duration Of Response (DOR)

  From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years)

• Disease Control Rate (DCR)

  From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (approximately 2 years)

• Overall Survival (OS)

  From the date of the first dose of study drug until death, or withdrawal of consent or long-term extension (LTE) phase initiates, whichever occurs first (approximately 2 years)

• Number of Participants With an Adverse Event

  Screening up to end of study (approximately 2 years)

Study Arms (1)

Erdafitinib

EXPERIMENTAL

Participants will receive a 8 milligram (mg) starting dose once daily with option to up-titrate to 9 mg on a 28-day cycle. The dose of study drug may be modified, delayed, or terminated based on guidelines provided in the protocol.

Drug: Erdafitinib

Interventions

Erdafitinib DRUG

Participants will receive 8 mg of erdafitinib, once daily with option to up-titrate to 9 mg.

Also known as: JNJ-42756493

Erdafitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically confirmed, advanced or refractory tumors (there are no restriction on the total number of lines of prior therapies, but participant should have received at least 1 line of anti-cancer therapy \[as per local standard of care\]): Squamous and non-squamous non-small-cell lung cancer (NSCLC), esophageal cancer, urothelial cancer and cholangiocarcinoma
• Participants must meet the following molecular eligibility criteria (diagnosed at a central or local laboratory using either a tumor tissue based assay, which must indicate: at least one of following): a) fibroblast growth factor receptor (FGFR) gene translocations b) FGFR gene mutations c) Participants with evidence of FGFR pathway activation or other potential target/pathway inhibited by erdafitinib may also be considered and allowed for enrollment if supported by emerging biomarker data.
• 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 male participants (with a partner of child bearing potential) must use medically acceptable methods of birth control. Male participants must use highly effective birth 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 of Cycle 1 up until pre-dose of Cycle 1

You may not qualify if:

• Chemotherapy, targeted therapies, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug whichever is longer up to a maximum of 4 weeks before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to 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 of Cycle 1) and despite medical management of phosphate levels
• Participants taking medications known to have a significant risk of causing QTc prolongation and Torsades de Pointes. Participants who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-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 by echocardiography (or multi-gated acquisition \[MUGA\]) performed at Screening
• Uncontrolled inter-current illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection requiring antibiotics, psychiatric illness, or at risk of gastrointestinal perforation as per investigators' assessment
• Received prior selective FGFR inhibitor treatment or RET inhibitor treatment, respectively according to the biomarker prescreening result, or if the participant has known allergies, hypersensitivity, or intolerance to Erdafitinib or its excipients
• Any corneal or retinal abnormality likely to increase risk of eye toxicity

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (6)

Unknown Facility

Beijing, China

Location

Unknown Facility

Harbin, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Related Publications (1)

• Park JO, Feng YH, Su WC, Oh DY, Keam B, Shen L, Kim SW, Liu X, Liao H, Qing M, Zhang C, Qian J, Tang X, Li P, Triantos S, Sweiti H. Erdafitinib in Asian patients with advanced solid tumors: an open-label, single-arm, phase IIa trial. BMC Cancer. 2024 Aug 13;24(1):1006. doi: 10.1186/s12885-024-12584-0.

  PMID: 39138436 DERIVED

MeSH Terms

Conditions

Neoplasms; Acrocephalosyndactylia; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Cholangiocarcinoma

Interventions

erdafitinib

Condition Hierarchy (Ancestors)

Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: July 8, 2016
• Primary Completion: October 12, 2021
• Study Completion: March 15, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

TW (2); CN (3); KR (1)