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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03390504




Registration number
NCT03390504
Ethics application status
Date submitted
20/12/2017
Date registered
4/01/2018
Date last updated
26/06/2020

Titles & IDs
Public title
A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
Scientific title
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
Secondary ID [1] 0 0
2017-002932-18
Secondary ID [2] 0 0
CR108401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Erdafitinib
Treatment: Drugs - Vinflunine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Pembrolizumab
Treatment: Devices - Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)

Experimental: Cohort 1 (Arm 1A): Erdafitinib - Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).

Experimental: Cohort 1 (Arm 1B): Vinflunine or Docetaxel - Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.

Experimental: Cohort 2 (Arm 2A): Erdafitinib - Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).

Experimental: Cohort 2 (Arm 2B): Pembrolizumab - Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.


Treatment: Drugs: Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.

Treatment: Drugs: Vinflunine
Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.

Treatment: Drugs: Docetaxel
Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.

Treatment: Drugs: Pembrolizumab
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.

Treatment: Devices: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.
Timepoint [1] 0 0
Date of first randomization to the date of participant's death (approximately up to 3 years)
Secondary outcome [1] 0 0
Progression-free Survival (PFS) - PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST v1.1] by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.
Timepoint [1] 0 0
Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years)
Secondary outcome [2] 0 0
Overall Response Rate (ORR) - ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.
Timepoint [2] 0 0
Approximately up to 3 years
Secondary outcome [3] 0 0
Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl) - The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.
Timepoint [3] 0 0
Baseline up to end of treatment (approximately 3 years)
Secondary outcome [4] 0 0
Change from Baseline in Patient-Global Impression of Severity (PGIS) Score - The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.
Timepoint [4] 0 0
Baseline up to end of treatment (approximately 3 years)
Secondary outcome [5] 0 0
Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L - European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.
Timepoint [5] 0 0
Baseline up to follow up phase (approximately 3 years)
Secondary outcome [6] 0 0
Change from Baseline in the Utility Scale of the EQ-5D-5L - The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
Timepoint [6] 0 0
Baseline up to follow up phase (approximately 3 years)
Secondary outcome [7] 0 0
Duration of Response (DOR) - DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.
Timepoint [7] 0 0
From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)
Secondary outcome [8] 0 0
Number of Participants with Adverse Events (AEs) as a Measure of Safety - 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.
Timepoint [8] 0 0
Approximately up to 3 years
Secondary outcome [9] 0 0
Oral Clearance (CL/F) of Erdafitinib - CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.
Timepoint [9] 0 0
Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)
Secondary outcome [10] 0 0
Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib - AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.
Timepoint [10] 0 0
Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)

Eligibility
Key inclusion criteria
- Histologic demonstration of transitional cell carcinoma of the urothelium. Minor
components ( less than [<] 50 percent [%] overall) of variant histology such as
glandular or squamous differentiation, or evolution to more aggressive phenotypes such
as sarcomatoid or micropapillary change are acceptable

- Metastatic or surgically unresectable urothelial cancer

- Documented progression of disease, defined as any progression that requires a change
in treatment, prior to randomization

- Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination
therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior
treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment.
Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease
progression within 12 months of the last dose are considered to have received systemic
therapy in the metastatic setting.

- A woman of childbearing potential who is sexually active must have a negative
pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or
serum)

- Participants must meet appropriate molecular eligibility criteria

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

- Adequate bone marrow, liver, and renal function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 30 days prior to randomization

- Active malignancies (that is, requiring treatment change in the last 24 months). The
only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24
months that is considered completely cured, localized prostate cancer with a gleason
score of 6 (treated within the last 24 months or untreated and under surveillance) and
localized prostate cancer with a gleason score of 3+4 that has been treated more than
6 months prior to full study screening and considered to have a very low risk of
recurrence.

- Symptomatic central nervous system metastases

- Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment

- Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients

- Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of
any grade.

- History of uncontrolled cardiovascular disease

- Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers,
known gastric ulcers, or unhealed incisions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
Frankston Hospital - Melbourne
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3199 - Melbourne
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
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Roma
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or
pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast
growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments,
at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not
containing an anti-PD-(L) 1 agent (cohort 2).
Trial website
https://clinicaltrials.gov/show/NCT03390504
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trials
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03390504