A Phase 2 interventional study of Testosterone undecanoate and sunitinib or pazopanib in Metastatic Renal Cell Carcinoma, sponsored by Kidney Cancer Research Bureau. Completed at 4 sites in Russian Federation. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Kidney Cancer Research Bureau · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Testosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)
Drug: Testosterone undecanoate and sunitinib or pazopanib
Targeted therapy (sunitinib or pazopanib) only
Drug: Testosterone undecanoate and sunitinib or pazopanib
Testosterone undecanoate (Nebido®) 1,000 mg (4 ml) intramuscular deeply, once before targeted therapy (sunitinib 50 mg 4/2 or pazopanib 800 mg daily)
Fatigue
Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone.
Time frame: 3 months
Safety and tolerability
Safety and tolerability of testosterone (CTCAE v.4.03)
Time frame: 3 months
Quality of life
Health-related quality of life (NCCN-FACT FKSI-19 (Version 2)
Time frame: 3 months
Overall rate of adverse events
Overall rate of adverse events related with TKI treatment (CTCAE v.4.03)
Time frame: 3 months
Testosterone serum concentrations
Maximum and minimum total testosterone serum concentrations following dose administration at week 12
Time frame: 12 weeks
Red blood cell count and Hemoglobin concentration
Change in Red blood cell count and Hemoglobin concentration following dose administration at week 12
Time frame: 12 weeks
Serum calcium concentration
Change in serum calcium concentration following dose administration at week 12
Time frame: 12 weeks
ECOG PS
ECOG Performance status
Time frame: 3 months
Overall survival
Time from randomization to death
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Kidney Cancer Research Bureau