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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699606
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Neoplasm Drug: Erdafitinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 8, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : February 28, 2021


Arm Intervention/treatment
Experimental: Erdafitinib
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
Participants will receive 8 mg of erdafitinib, once daily with option to up-titrate to 9 mg.
Other Name: JNJ-42756493




Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    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]).

  4. 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) ]
    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.

  5. Number of Participants With an Adverse Event [ Time Frame: Screening up to end of study (approximately 2 years) ]
  6. Plasma Concentration of Erdafitinib [ Time Frame: Approximately up to 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699606


Locations
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China
Beijing, China
Harbin, China
Nanjing, China
Korea, Republic of
Seoul, Korea, Republic of
Taiwan
Kaohsiung, Taiwan
Tainan, Taiwan
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02699606    
Other Study ID Numbers: CR108120
42756493LUC2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Tumor
Fibroblast Growth Factor Receptor (FGFR)
Non-Small Cell Lung Cancer (NSCLC)
Erdafitinib
Urothelial Cancer
Esophageal Cancer
Cholangiocarcinoma
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasms
Cholangiocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
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