Clinical trial NCT03379012: Testosterone in Metastatic Renal Cell Carcinoma Patients
Official title: Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fatigue
timeFrame: 3 months
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Overall rate of adverse events
timeFrame: 3 months
measure: Testosterone serum concentrations
timeFrame: 12 weeks
measure: Red blood cell count and Hemoglobin concentration
timeFrame: 12 weeks
measure: Serum calcium concentration
timeFrame: 12 weeks
measure: ECOG PS
timeFrame: 3 months
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Krasnoyarsk
country: Russian Federation
facility: A.I. Kryzhanovsky Krasnoyarsk Cancer Center
city: Moscow
country: Russian Federation
facility: Kidney Cancer Research Bureau
city: Moscow
country: Russian Federation
facility: RUDN University
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Oncology Center
Study officials:
References:
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