Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue
Purpose
To determine efficacy and safety of Testosterone in male patients with metastatic renal cell
carcinoma and fatigue receiving targeted therapy or checkpoint inhibitors.
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.
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