Testosterone in Metastatic Renal Cell Carcinoma Patients (FARETES)

October 18, 2019 updated by: Kidney Cancer Research Bureau

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Krasnoyarsk, Russian Federation
        • A.I. Kryzhanovsky Krasnoyarsk Cancer Center
      • Moscow, Russian Federation
        • Kidney Cancer Research Bureau
      • Moscow, Russian Federation
        • RUDN University
      • Saint Petersburg, Russian Federation
        • City Clinical Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Testosterone and Targeted therapy
Testosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)
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)
ACTIVE_COMPARATOR: Control
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 3 months
Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 3 months
Safety and tolerability of testosterone (CTCAE v.4.03)
3 months
Quality of life
Time Frame: 3 months
Health-related quality of life (NCCN-FACT FKSI-19 (Version 2)
3 months
Overall rate of adverse events
Time Frame: 3 months
Overall rate of adverse events related with TKI treatment (CTCAE v.4.03)
3 months
Testosterone serum concentrations
Time Frame: 12 weeks
Maximum and minimum total testosterone serum concentrations following dose administration at week 12
12 weeks
Red blood cell count and Hemoglobin concentration
Time Frame: 12 weeks
Change in Red blood cell count and Hemoglobin concentration following dose administration at week 12
12 weeks
Serum calcium concentration
Time Frame: 12 weeks
Change in serum calcium concentration following dose administration at week 12
12 weeks
ECOG PS
Time Frame: 3 months
ECOG Performance status
3 months
Overall survival
Time Frame: 2 years
Time from randomization to death
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kidney Cancer Research Bureau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2016

Primary Completion (ACTUAL)

January 30, 2018

Study Completion (ACTUAL)

July 30, 2019

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (ACTUAL)

December 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCRB08022016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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