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Testosterone in Metastatic Renal Cell Carcinoma Patients (FARETES)

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Testosterone undecanoate and sunitinib or pazopanib
Sponsored by
Kidney Cancer Research Bureau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • A.I. Kryzhanovsky Krasnoyarsk Cancer Center
  • Kidney Cancer Research Bureau
  • RUDN University
  • City Clinical Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Testosterone and Targeted therapy

Control

Arm Description

Testosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)

Targeted therapy (sunitinib or pazopanib) only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2017
Last Updated
October 18, 2019
Sponsor
Kidney Cancer Research Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT03379012
Brief Title
Testosterone in Metastatic Renal Cell Carcinoma Patients
Acronym
FARETES
Official Title
Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2016 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kidney Cancer Research Bureau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone and Targeted therapy
Arm Type
Experimental
Arm Description
Testosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Targeted therapy (sunitinib or pazopanib) only
Intervention Type
Drug
Intervention Name(s)
Testosterone undecanoate and sunitinib or pazopanib
Intervention Description
Testosterone undecanoate (Nebido®) 1,000 mg (4 ml) intramuscular deeply, once before targeted therapy (sunitinib 50 mg 4/2 or pazopanib 800 mg daily)
Primary Outcome Measure Information:
Title
Fatigue
Description
Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Safety and tolerability of testosterone (CTCAE v.4.03)
Time Frame
3 months
Title
Quality of life
Description
Health-related quality of life (NCCN-FACT FKSI-19 (Version 2)
Time Frame
3 months
Title
Overall rate of adverse events
Description
Overall rate of adverse events related with TKI treatment (CTCAE v.4.03)
Time Frame
3 months
Title
Testosterone serum concentrations
Description
Maximum and minimum total testosterone serum concentrations following dose administration at week 12
Time Frame
12 weeks
Title
Red blood cell count and Hemoglobin concentration
Description
Change in Red blood cell count and Hemoglobin concentration following dose administration at week 12
Time Frame
12 weeks
Title
Serum calcium concentration
Description
Change in serum calcium concentration following dose administration at week 12
Time Frame
12 weeks
Title
ECOG PS
Description
ECOG Performance status
Time Frame
3 months
Title
Overall survival
Description
Time from randomization to death
Time Frame
2 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
A.I. Kryzhanovsky Krasnoyarsk Cancer Center
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Kidney Cancer Research Bureau
City
Moscow
Country
Russian Federation
Facility Name
RUDN University
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Oncology Center
City
Saint Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27279544
Citation
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.
Results Reference
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PubMed Identifier
17215529
Citation
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.
Results Reference
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PubMed Identifier
23598172
Citation
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. Erratum In: Lancet Oncol. 2013 Jun;14(7):e254.
Results Reference
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PubMed Identifier
23321547
Citation
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.
Results Reference
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PubMed Identifier
26482279
Citation
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. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270. Lancet Oncol. 2018 Oct;19(10):e509.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Testosterone in Metastatic Renal Cell Carcinoma Patients

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