Metastatic Renal Cell Carcinoma
Conditions
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.
Interventions
DRUGTestosterone 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)
Sponsors
Kidney Cancer Research Bureau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically proven clear cell renal cell carcinoma; 2. CT-confirmed metastatic measurable disease; 3. First-line sunitinib or pazopanib treatment with fatigue; 4. Low level of testosterone; 4\. Male, 18 years and older; 5. Normal PSA level
Exclusion criteria
1. Prostate and other cancers history 2. Hypothyroidism 3. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 3 months | Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 3 months | Health-related quality of life (NCCN-FACT FKSI-19 (Version 2) |
| Overall rate of adverse events | 3 months | Overall rate of adverse events related with TKI treatment (CTCAE v.4.03) |
| Testosterone serum concentrations | 12 weeks | Maximum and minimum total testosterone serum concentrations following dose administration at week 12 |
| Safety and tolerability | 3 months | Safety and tolerability of testosterone (CTCAE v.4.03) |
| Serum calcium concentration | 12 weeks | Change in serum calcium concentration following dose administration at week 12 |
| ECOG PS | 3 months | ECOG Performance status |
| Overall survival | 2 years | Time from randomization to death |
| Red blood cell count and Hemoglobin concentration | 12 weeks | Change in Red blood cell count and Hemoglobin concentration following dose administration at week 12 |
Countries
Russia
Outcome results
None listed