Urothelial cancer MedDRA version: 18.1 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: JNJ-42756493 5 mg tablets (G018)
Product Code: JNJ-42756493 5 mg tablets (G018)
Pharmaceutical Form: Tablet
INN or Proposed INN: Not assig
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
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. Subjects 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 subjects will be referred to as chemorefractory subjects. (Subjects who have shown disease progression according to RECIST, version 1.1 following prior treatment with antiProgrammed deathligand 1 (anti PDL1/PD1) antibodies are also eligible) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115
Exclusion criteria
Exclusion criteria: - Received chemotherapy, targeted therapies, definitive radiotherapy, immunotherapy, 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 |
|---|---|
| Main Objective: The primary objective of the study is: * To evaluate the objective response rate of the selected dose regimen out of 2 possible dose regimens (Regimen 1: 10 mg dose once daily, 7 days on/7 days off; and regimen 2: 6 mg dose, once daily; for 28 day cycles) in subjects with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations. ; Secondary Objective: The secondary objectives of the study are: * To evaluate the objective response rate in chemo-refractory subjects * To evaluate the progression-free survival (PFS), duration of response, and overall survival in all and chemo-refractory subjects *To evaluate the response rate in biomarker-specific subgroups (translocations versus mutations) * To evaluate the safety and pharmacokinetics of JNJ-42756493 at the 2 dose regimens ;Primary end point(s): Percentage of Participants with Best Overall Response;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression-free survival 2. Duration of Response 3. Overall survival 4. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) 5. Biomarker Assessment 6. Plasma Concentration of JNJ 42756493 7. Plasma Clearance of JNJ 42756493 8. Volume of Distribution of JNJ 42756493 ; Timepoint(s) of evaluation of this end point: 1/2. 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 (approx 3yrs 9m) 3. From the date of the first dose of study drug until death (up to 3yrs 9m) 4. Screening up to end of study (approx 3yrs 9m) 5/6/7/8. Baseline up to end of study (approx 3 years 9 months) | — |
Countries
Austria, Belgium, France, Germany, Israel, Italy, Korea, Republic of, Moldova, Republic of, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed