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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

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ClinicalTrials.gov Identifier: NCT02699606
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : December 7, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
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 : May 31, 2019
Estimated Study Completion Date : October 31, 2019


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

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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


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
China
Beijing Cancer Hospital of Peking University Withdrawn
Beijing, China, 100048
Beijing Cancer Hospital of Peking University Recruiting
Beijing, China, 100048
Peking Union Medical College Hospital Withdrawn
Beijing, China, 100730
Chongqing Cancer hospital Withdrawn
Chongqing, China, 400030
Sun Yat-Sen University Cancer Center Withdrawn
Guangzhou, China, 430030
Sun Yat-Sen Memorial Hospital Sun Yat-sen University Withdrawn
Guangzhou, China, 510120
Harbin medical university cancer hospital Recruiting
Harbin, China, 150000
Jiangsu Cancer Hospital Withdrawn
Nanjing, China, 210009
The 81st Hospital of PLA. Recruiting
Nanjing, China
Fudan University Shanghai Cancer Center Withdrawn
Shanghai, China, 200032
Shanghai Zhongshan Hospital Withdrawn
Shanghai, China, 200032
ShangHai Huadong Hospital Withdrawn
Shanghai, China, 200050
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of, 06351
Taiwan
Chang Gung Medical Foundation Recruiting
Kaohsiung, Taiwan, 833
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Chi Mei Medical Center - Yong Kang Recruiting
Tainan, Taiwan, 710
Chi Mei Medical Center - Liu Ying Recruiting
Tainan, Taiwan, 736
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02699606     History of Changes
Other Study ID Numbers: CR108120
42756493LUC2001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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:
Cholangiocarcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasms
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
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action