The study is to understand the efficacy and safety of the enzalutamide maintenance therapy in the patients with advanced/metastatic urothelial cancers.
- Conditions
- Health Condition 1: C679- Malignant neoplasm of bladder, unspecifiedHealth Condition 2: N328- Other specified disorders of bladder
- Registration Number
- CTRI/2023/04/051518
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method