Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Erdafitinib: 8 mg orally once daily for 28 days on a 28 day cycle.
Intervention2: Midazolam: DDI substudy will receive pretreatment with single dose of midazolam 2.5mg oral solution on
Sponsors
Janssen Research Development LLC
Eligibility
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
Belgium, France, India, Spain, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Pvt. Ltd.
Outcome results
None listed