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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

Description:

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.

Related Conditions:
  • Cholangiocarcinoma
  • Esophageal Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: A Phase 2a Study to Evaluate The Clinical Efficacy of JNJ-42756493, A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Patients With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Gastric Cancer, Esophageal Cancer Or Cholangiocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: CR108120
  • SECONDARY ID: 42756493LUC2001
  • NCT ID: NCT02699606

Conditions

  • Neoplasm

Interventions

DrugSynonymsArms
ErdafitinibJNJ-42756493Erdafitinib

Purpose

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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions
ErdafitinibExperimentalParticipants 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.
  • Erdafitinib

Eligibility Criteria

        Inclusion Criteria:

          -  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 Response Evaluation Criteria in
             Solid Tumors (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

        Exclusion Criteria:

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame: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)
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame: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)
Safety Issue:
Description:Duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
Measure:Duration Of Response (DOR)
Time Frame: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)
Safety Issue:
Description:Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
Measure:Disease Control Rate (DCR)
Time Frame: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)
Safety Issue:
Description:DCR defined as the proportion of participants with complete response [CR], partial response [PR], or greater than or equal to (>=) 6 weeks stable disease [SD]).
Measure:Overall Survival (OS)
Time Frame:From the date of the first dose of study drug until death, or withdrawal of consent or conclusion of the study, whichever occurs first (approximately 2 years)
Safety Issue:
Description:The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
Measure:Number of Participants With an Adverse Event
Time Frame:Screening up to end of study (approximately 2 years)
Safety Issue:
Description:
Measure:Plasma Concentration of Erdafitinib
Time Frame:Approximately up to 16 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Trial Keywords

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

Last Updated

January 2, 2020