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Metastatic Renal Cell CarcinomaPhase 2FARETESNCT03379012

Testosterone in Metastatic Renal Cell Carcinoma Patients

A Phase 2 study testing Testosterone undecanoate and sunitinib or pazopanib in people with Metastatic Renal Cell Carcinoma, run by Kidney Cancer Research Bureau at 4 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
Testosterone undecanoate and sunitinib or pazopanib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesRussia
Study dates
8 Feb 2016to 30 Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven clear cell renal cell carcinoma;
  • CT-confirmed metastatic measurable disease;
  • First-line sunitinib or pazopanib treatment with fatigue;
  • Low level of testosterone;
  • 4. Male, 18 years and older; 5. Normal PSA level

Who cannot join

  • Prostate and other cancers history
  • Hypothyroidism
  • 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)

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

  • A.I. Kryzhanovsky Krasnoyarsk Cancer Center

    Krasnoyarsk

  • Kidney Cancer Research Bureau

    Moscow

  • RUDN University

    Moscow

  • City Clinical Oncology Center

    Saint Petersburg

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
Testosterone undecanoate and sunitinib or pazopanib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone undecanoate and sunitinib or pazopanibDrug

    Testosterone undecanoate (Nebido®) 1,000 mg (4 ml) intramuscular deeply, once before targeted therapy (sunitinib 50 mg 4/2 or pazopanib 800 mg daily)

Study groups in NCT03379012
Study groupRoleWhat they receive
Testosterone and Targeted therapyExperimentalTestosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)
Receives: Drug: Testosterone undecanoate and sunitinib or pazopanib
ControlActive comparatorTargeted therapy (sunitinib or pazopanib) only
Receives: Drug: Testosterone undecanoate and sunitinib or pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue

    Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone.

    Measured: 3 months

Secondary outcomes (8)

  1. Safety and tolerability

    Safety and tolerability of testosterone (CTCAE v.4.03)

    Measured: 3 months

  2. Quality of life

    Health-related quality of life (NCCN-FACT FKSI-19 (Version 2)

    Measured: 3 months

  3. Overall rate of adverse events

    Overall rate of adverse events related with TKI treatment (CTCAE v.4.03)

    Measured: 3 months

  4. Testosterone serum concentrations

    Maximum and minimum total testosterone serum concentrations following dose administration at week 12

    Measured: 12 weeks

  5. Red blood cell count and Hemoglobin concentration

    Change in Red blood cell count and Hemoglobin concentration following dose administration at week 12

    Measured: 12 weeks

  6. Serum calcium concentration

    Change in serum calcium concentration following dose administration at week 12

    Measured: 12 weeks

  7. ECOG PS

    ECOG Performance status

    Measured: 3 months

  8. Overall survival

    Time from randomization to death

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2017
  2. Study start8 Feb 2016
  3. Primary completion30 Jan 2018
  4. Study completion30 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03379012
Sponsor's protocol ID
KCRB08022016
Acronym
FARETES
Status last verified
Oct 2019
First submitted
13 Oct 2017
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.

    PubMed 27279544

  • Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.

    PubMed 17215529

  • Motzer RJ, Escudier B, Tomczak P, Hutson TE, Michaelson MD, Negrier S, Oudard S, Gore ME, Tarazi J, Hariharan S, Chen C, Rosbrook B, Kim S, Rini BI. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013 May;14(6):552-62. doi: 10.1016/S1470-2045(13)70093-7. Epub 2013 Apr 16.

    PubMed 23598172

  • Sternberg CN, Hawkins RE, Wagstaff J, Salman P, Mardiak J, Barrios CH, Zarba JJ, Gladkov OA, Lee E, Szczylik C, McCann L, Rubin SD, Chen M, Davis ID. A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: final overall survival results and safety update. Eur J Cancer. 2013 Apr;49(6):1287-96. doi: 10.1016/j.ejca.2012.12.010. Epub 2013 Jan 12.

    PubMed 23321547

  • Motzer RJ, Hutson TE, Glen H, Michaelson MD, Molina A, Eisen T, Jassem J, Zolnierek J, Maroto JP, Mellado B, Melichar B, Tomasek J, Kremer A, Kim HJ, Wood K, Dutcus C, Larkin J. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. 2015 Nov;16(15):1473-1482. doi: 10.1016/S1470-2045(15)00290-9. Epub 2015 Oct 22.

    PubMed 26482279

  • Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N, Kay A, Ravaud A; RECORD-1 Study Group. Phase 3 trial of everolimus for metastatic renal cell carcinoma : final results and analysis of prognostic factors. Cancer. 2010 Sep 15;116(18):4256-65. doi: 10.1002/cncr.25219.

    PubMed 20549832

  • Tomita Y, Fukasawa S, Shinohara N, Kitamura H, Oya M, Eto M, Tanabe K, Kimura G, Yonese J, Yao M, Motzer RJ, Uemura H, McHenry MB, Berghorn E, Ozono S. Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup analysis from the CheckMate 025 study. Jpn J Clin Oncol. 2017 Jul 1;47(7):639-646. doi: 10.1093/jjco/hyx049.

    PubMed 28419248

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone undecanoate and sunitinib or pazopanib in people with Metastatic Renal Cell Carcinoma, run by Kidney Cancer Research Bureau at 4 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03379012, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.

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