Status:
COMPLETED
Testosterone in Metastatic Renal Cell Carcinoma Patients
Lead Sponsor:
Kidney Cancer Research Bureau
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Purpose To determine efficacy and safety of Testosterone in male patients with metastatic renal cell carcinoma and fatigue receiving targeted therapy or checkpoint inhibitors.
Detailed Description
Fatigue is a frequent symptom of metastatic renal cell carcinoma (RCC), and most common adverse event of targeted and immunotherapy. In Phase 3 pivotal studies, 56% (9%, grade 3-4), 54% (11%, grade 3...
Eligibility Criteria
Inclusion
- Histologically proven clear cell renal cell carcinoma;
- CT-confirmed metastatic measurable disease;
- First-line sunitinib or pazopanib treatment with fatigue;
- Low level of testosterone;
- 4\. Male, 18 years and older; 5. Normal PSA level
Exclusion
- Prostate and other cancers history
- Hypothyroidism
- History of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
Key Trial Info
Start Date :
February 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03379012
Start Date
February 8 2016
End Date
July 30 2019
Last Update
October 22 2019
Active Locations (4)
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1
A.I. Kryzhanovsky Krasnoyarsk Cancer Center
Krasnoyarsk, Russia
2
Kidney Cancer Research Bureau
Moscow, Russia
3
RUDN University
Moscow, Russia
4
City Clinical Oncology Center
Saint Petersburg, Russia