Testosterone in Metastatic Renal Cell Carcinoma Patients

Phase 2

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Testosterone undecanoate and sunitinib or pazopanib

• Registration Number: NCT03379012
• Lead Sponsor: Kidney Cancer Research Bureau

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.

Study Timeline

• Study Start: 2016-02-08
• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Primary Completion: 2018-01-30
• Study Completion: 2019-07-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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;

5. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone and Targeted therapy	Testosterone undecanoate and sunitinib or pazopanib	Testosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)
Control	Testosterone undecanoate and sunitinib or pazopanib	Targeted therapy (sunitinib or pazopanib) only

Primary Outcome Measures

Name	Time	Method
Fatigue	3 months	Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	3 months	Safety and tolerability of testosterone (CTCAE v.4.03)
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
Red blood cell count and Hemoglobin concentration	12 weeks	Change in Red blood cell count and Hemoglobin concentration following dose administration at week 12
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

Trial Locations

Locations (4)

A.I. Kryzhanovsky Krasnoyarsk Cancer Center; 🇷🇺 Krasnoyarsk, Russian Federation

Kidney Cancer Research Bureau; 🇷🇺 Moscow, Russian Federation

RUDN University; 🇷🇺 Moscow, Russian Federation

City Clinical Oncology Center; 🇷🇺 Saint Petersburg, Russian Federation