NCT03379012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 13, 2017

Last Update Submit

October 18, 2019

Conditions

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Fatigue

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

    3 months

Secondary Outcomes (8)

  • Safety and tolerability

    3 months

  • Quality of life

    3 months

  • Overall rate of adverse events

    3 months

  • Testosterone serum concentrations

    12 weeks

  • Red blood cell count and Hemoglobin concentration

    12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Testosterone and Targeted therapy

EXPERIMENTAL

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

Drug: Testosterone undecanoate and sunitinib or pazopanib

Control

ACTIVE COMPARATOR

Targeted therapy (sunitinib or pazopanib) only

Drug: Testosterone undecanoate and sunitinib or pazopanib

Interventions

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)

ControlTestosterone and Targeted therapy

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

A.I. Kryzhanovsky Krasnoyarsk Cancer Center

Krasnoyarsk, Russia

Location

Kidney Cancer Research Bureau

Moscow, Russia

Location

RUDN University

Moscow, Russia

Location

City Clinical Oncology Center

Saint Petersburg, Russia

Location

Related Publications (7)

  • 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.

    PMID: 27279544BACKGROUND

  • 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.

    PMID: 17215529BACKGROUND

  • 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.

    PMID: 23598172BACKGROUND

  • 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.

    PMID: 23321547BACKGROUND

  • 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.

    PMID: 26482279BACKGROUND

  • 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.

    PMID: 20549832BACKGROUND

  • 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.

    PMID: 28419248BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

testosterone undecanoateSunitinibpazopanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2017

First Posted

December 20, 2017

Study Start

February 8, 2016

Primary Completion

January 30, 2018

Study Completion

July 30, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

RU(4)