Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue
Overview
- Phase
- Phase 2
- Intervention
- Testosterone undecanoate and sunitinib or pazopanib
- Conditions
- Metastatic Renal Cell Carcinoma
- Sponsor
- Kidney Cancer Research Bureau
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Fatigue
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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), 37% (10%, grade 3-4) and 20% (2%, grade 3) of patients had fatigue during the therapy of cabozantinib, sunitinib, axitinib or pazopanib, respectively. 59% (14%, grade 3) and 31% (5%, grade 3) of patients treated with lenvatinib/everolimus and everolimus had fatigue in registrational trials. Finally, 33% (2%, grade 3-4) of patients that received nivolumab had fatigue in CheckMate 025 study. Testosterone may help to relieve fatigue associated with the use of tyrosine kinase, mTOR or checkpoint inhibitors. Additionally, testosterone could impact on poor prognostic factors of RCC (anemia, ECOG performance status, serum calcium). This will be first clinical trial which evaluates safety and efficacy of Testosterone in RCC patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven clear cell renal cell carcinoma;
- •CT-confirmed metastatic measurable disease;
- •First-line sunitinib or pazopanib treatment with fatigue;
- •Low level of testosterone;
- •Male, 18 years and older;
- •Normal PSA level
Exclusion Criteria
- •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)
Arms & Interventions
Testosterone and Targeted therapy
Testosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)
Intervention: Testosterone undecanoate and sunitinib or pazopanib
Control
Targeted therapy (sunitinib or pazopanib) only
Intervention: Testosterone undecanoate and sunitinib or pazopanib
Outcomes
Primary Outcomes
Fatigue
Time Frame: 3 months
Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone.
Secondary Outcomes
- Safety and tolerability(3 months)
- Quality of life(3 months)
- Overall rate of adverse events(3 months)
- Testosterone serum concentrations(12 weeks)
- Red blood cell count and Hemoglobin concentration(12 weeks)
- Serum calcium concentration(12 weeks)
- ECOG PS(3 months)
- Overall survival(2 years)