Health Condition 1: C679- Malignant neoplasm of bladder, unspecified Health Condition 2: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: gfhjh: hgyuf
Intervention2: Oral dose of enzalutamide 160mg along with platinum-based therapy: AR Positive Urothelial Cancer patients will be given oral dose of enzalutamide 160mg once
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1Advanced or metastatic urothelial cancer 2Androgen receptor positive patients who are planned to receive platinum-based therapy or has been started on Platinum based chemotherapy in the last 4 weeks 3Age- Age >=18 years 4Performance Status - 0 - 2 5Glomerular Filtration Rate > 30 mL per min 6Ejection fraction > 45% 7Both men and women of all races and ethnics groups eligible for this trial 8Willing and able to comply with all study requirements 9Able to understand and willing to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1Patients who are currently receiving any other investigational agents. 2History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 3Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure on dialysis, active gastrointestinal bleeding, cerebrovascular accidents within last 1 year, inflammatory bowel disease, known hyperkaliemia CTCAE version 5 grade 3 or above which is persistent over 1 week or psychiatric illness or social situations that would limit compliance with study requirements. Patients who have uncontrolled hypertension or diabetes or other chronic medical conditions at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility. 4Pregnant women and breastfeeding women are excluded from this study because Chemotherapy agents have the potential for teratogenicity or abortifacient effects. 5Patients who are able to receive avelumab maintenance therapy both financially and medically fit for the same, will be excluded from this study 6Patients for whom it is mandatory to take drugs that inhibit CYP2C8 and induces CYP3A4 will be excluded from the study Appendix I 7Patient having history of seizures will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFSTimepoint: 6-months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OS 2. Adverse Events 3. QOL Timepoint: OS at 1 year Adverse events assessment in each visit 3 monthly QOL assessment | — |
Countries
India
Contacts
Public ContactMr Bhavesh P Bandekar
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)
Outcome results
None listed