An Efficacy and Safety Study of JNJ-42756493 in Participants With Urothelial Cancer
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|ClinicalTrials.gov Identifier: NCT02365597|
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2015
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Cancer||Drug: JNJ-42756493||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 22, 2015|
|Estimated Primary Completion Date :||September 28, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: JNJ-42756493 (8 milligram)
Prior to interim analysis 1 (IA1), there were 2 treatment regimens: Regimen 1 (10 milligram [mg] once daily, 7 days on/7 days off); and Regimen 2 (6 mg once daily for 28 days). Following IA1, Regimen 1 is closed for further enrollment and starting dose of Regimen 2 is increased to 8 mg once daily for 28 days on a 28-day cycle (referred to as Regimen 3).
8 mg orally once daily for 28 days on a 28 day cycle.
- Percentage of Participants with Best Overall Response [ Time Frame: 1 year ]The objective response rate is defined as the percentage of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST v1.1) criteria. Per RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Progression-free survival [ 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 3 years 9 months) ]Progression-free survival is defined as the 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 a complete response during the study) or death, whichever comes first.
- Duration of Response [ 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 3 years 9 months) ]The duration of response (CR or PR) is defined as the earliest date a participant achieved a complete response (CR) or a partial response (PR), calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
- Overall survival [ Time Frame: From the date of the first dose of study drug until death (up to 3 years 9 months) ]Overall survival is defined as the time interval in days between the date of the first dose of study drug and the participant's death from any cause. If the participant is alive or the vital status is unknown, the participant's data will be censored at the date the participant was last known to be alive.
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to end of study (approximately 3 years 9 months) ]An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
- Percentage of Participants With Biomarker Assessment [ Time Frame: Baseline up to end of study (approximately 3 years 9 months) ]Presence of circulating biomarkers (DNA, RNA, or proteins) associated with FGFR aberrations will be observed.
- Plasma Concentration of JNJ 42756493 [ Time Frame: Baseline up to end of study (approximately 3 years 9 months) ]
- Plasma Clearance of JNJ 42756493 [ Time Frame: Baseline up to end of study (approximately 3 years 9 months) ]
- Volume of Distribution of JNJ 42756493 [ Time Frame: Baseline up to end of study (approximately 3 years 9 months) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365597
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|