An Efficacy and Safety Study of Erdafitinib (JNJ42756493) in Participants with Urothelial Cancer
- Conditions
- Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
- Registration Number
- CTRI/2021/11/038016
- Lead Sponsor
- Janssen Research Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma Concentration of Midazolam and its Metabolite (1-OH midazolam)Timepoint: Plasma Concentration of Midazolam and its Metabolite (1-OH midazolam) at Day-2 and Day 15
- Secondary Outcome Measures
Name Time Method oneTimepoint: None