Clinical Trials /

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

NCT02365597

Description:

The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

An Efficacy and Safety Study of JNJ-42756493 in Participants With Urothelial <span class="go-doc-concept go-doc-disease">Cancer</span>

Title

  • Brief Title: An Efficacy and Safety Study of JNJ-42756493 in Participants With Urothelial Cancer
  • Official Title: A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations
  • Clinical Trial IDs

    NCT ID: NCT02365597

    ORG ID: CR105065

    NCI ID: 42756493BLC2001

    Trial Conditions

    Urothelial Cancer

    Trial Interventions

    Drug Synonyms Arms
    JNJ-42756493, 10 mg JNJ-42756493, Treatment Regimen 1
    JNJ-42756493, 6 mg JNJ-42756493, Treatment Regimen 2

    Trial Purpose

    The purpose of this study is to evaluate the objective response rate of the selected dose
    regimen out of 2 possible dose regimens of JNJ-42756493 in participants with metastatic or
    surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

    Detailed Description

    This is a 2-arm (group), multicenter, open-label study (participants will know the identity
    of study drugs administered) to evaluate the efficacy and safety of 2 different dose
    regimens of JNJ-42756493 in participants with urothelial cancer. The study comprises a
    30-days Screening Phase, a Treatment Phase comprised of 28-day treatment cycles that will
    continue until disease progression or unacceptable toxicity occurs, and a post-treatment
    Follow-up Phase that will extend from the End-of-Treatment Visit until the participant has
    died, withdraws consent, is lost to follow-up, or the end of the study, whichever comes
    first. The end of study is defined as approximately 12 months after last participant is
    enrolled. Safety will be monitored throughout the study.

    Trial Arms

    Name Type Description Interventions
    JNJ-42756493, Treatment Regimen 1 Experimental Participants will take a 10 milligram (mg) dose once daily for 7 consecutive days followed by a 7-day drug-free period (7 days on/7 days off) on a 28-day cycle. The dose of study drug may be modified, delayed, or terminated based on guidelines provided in the protocol. JNJ-42756493, 10 mg
    JNJ-42756493, Treatment Regimen 2 Experimental Participants will take a 6 mg dose once daily for 28-day cycles. The dose of study drug may be modified, delayed, or terminated based on guidelines provided in the protocol. JNJ-42756493, 6 mg

    Eligibility Criteria

    Inclusion Criteria:

    - Must have histologic demonstration of metastatic or surgically unresectable
    urothelial cancer. Minor components of variant histology such as glandular or
    squamous differentiation, or evolution to more aggressive phenotypes such as
    sarcomatoid or micropapillary change are acceptable

    - Must have measurable disease according to the Response Evaluation Criteria in Solid
    Tumors (RECIST, version 1.1) at baseline

    - Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1,
    or 2

    - Must have adequate bone marrow, liver, and renal function as described in protocol

    - Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at
    Screening for women of child bearing potential who are sexually active

    - Must have shown disease progression according to RECIST, version 1.1, following prior
    chemotherapy for metastatic or surgically unresectable urothelial cancer. Subjects
    who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or
    progression according to RECIST, version 1.1, within 12 months of the last dose are
    considered to have received chemotherapy in the metastatic setting. These subjects
    will be referred to as chemo-refractory subjects. (Subjects who have shown disease
    progression according to RECIST, version 1.1 following prior treatment with
    anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible)

    Exclusion Criteria:

    - Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with
    an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and
    mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the
    first administration of study drug. Localized palliative radiation therapy (but
    should not include radiation to target lesions) and ongoing bisphosphonates and
    denosumab, are permitted

    - Has persistent phosphate level greater than upper limit of normal (ULN) during
    screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite
    medical management

    - Has a history of or current uncontrolled cardiovascular disease

    - Females who are pregnant, breast-feeding, or planning to become pregnant within 3
    months after the last dose of study drug and males who plan to father a child while
    enrolled in this study or within 5 months after the last dose of study drug

    - Has not recovered from reversible toxicity of prior anticancer therapy (except
    toxicities which are not clinically significant such as alopecia, skin discoloration,
    or Grade 1 neuropathy)

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Percentage of Participants with Best Overall Response

    Secondary Outcome Measures

    Progression-free survival

    Duration of Response

    Overall survival

    Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Percentage of Participants With Biomarker Assessment

    Plasma Concentration of JNJ 42756493

    Plasma Clearance of JNJ 42756493

    Volume of Distribution of JNJ 42756493

    Trial Keywords

    Urothelial Cancer

    JNJ-42756493

    Tyrosine Kinase Inhibitor