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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 August 2023
• Main ID: NCT02365597
• Date of registration: 29/01/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer
• Scientific 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
• Date of first enrolment: April 22, 2015
• Target sample size: 243
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02365597
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, France, Germany, India, Israel, Italy, Korea, Republic of, Moldova, Republic of, Romania, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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. Participants
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 participants
will be referred to as chemo-refractory participants. (Participants 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) For DDI
substudy

- Disease progression following prior chemotherapy for metastatic or surgically
unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant
chemotherapy and showed disease recurrence or progression within 12 months of the last
dose are considered to have received chemotherapy in the metastatic setting

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 ho 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Urothelial Cancer

Intervention(s)

Drug: Erdafitinib

Drug: Metformin

Drug: Midazolam

Primary Outcome(s)

Percentage of Participants with Best Overall Response [Time Frame: From the start of the study treatment until the end of treatment (1 year)]

Secondary Outcome(s)

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 (up to 5 years)]

Plasma Clearance of Erdafitinib [Time Frame: Baseline up to end of study (up to 5 years)]

Volume of Distribution of Erdafitinib [Time Frame: Baseline up to end of study (up to 5 years)]

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 (up to 5 years)]

Overall survival [Time Frame: From the date of the first dose of study drug until death (up to 5 years)]

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Screening up to end of study (up to 5 years)]

Plasma Concentration of Erdafitinib [Time Frame: Baseline up to end of study (up to 5 years)]

Percentage of Participants With Biomarker Assessment [Time Frame: Baseline up to end of study (up to 5 years)]

Plasma Concentration of Metformin [Time Frame: Up to 15 days]

Plasma Concentration of Midazolam and its Metabolite (1-OH-midazolam) [Time Frame: Up to 14 days]

Secondary ID(s)

2014-002408-26

CR105065

42756493BLC2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors