Testosterone in Metastatic Renal Cell Carcinoma Patients (FARETES)
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| ClinicalTrials.gov Identifier: NCT03379012 |
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Recruitment Status :
Completed
First Posted : December 20, 2017
Last Update Posted : October 22, 2019
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Purpose
To determine efficacy and safety of Testosterone in male patients with metastatic renal cell carcinoma and fatigue receiving targeted therapy or checkpoint inhibitors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Renal Cell Carcinoma | Drug: Testosterone undecanoate and sunitinib or pazopanib | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2 Randomized Study of Efficacy and Safety of Testosterone in Metastatic Renal Cell Carcinoma Patients With Fatigue |
| Actual Study Start Date : | February 8, 2016 |
| Actual Primary Completion Date : | January 30, 2018 |
| Actual Study Completion Date : | July 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Testosterone and Targeted therapy
Testosterone undecanoate (Nebido®) and Targeted therapy (sunitinib or pazopanib)
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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) |
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Active Comparator: Control
Targeted therapy (sunitinib or pazopanib) only
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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) |
- Fatigue [ Time Frame: 3 months ]Difference in mean change of Fatigue from baseline score with testosterone vs. without testosterone.
- Safety and tolerability [ Time Frame: 3 months ]Safety and tolerability of testosterone (CTCAE v.4.03)
- Quality of life [ Time Frame: 3 months ]Health-related quality of life (NCCN-FACT FKSI-19 (Version 2)
- Overall rate of adverse events [ Time Frame: 3 months ]Overall rate of adverse events related with TKI treatment (CTCAE v.4.03)
- Testosterone serum concentrations [ Time Frame: 12 weeks ]Maximum and minimum total testosterone serum concentrations following dose administration at week 12
- 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
- Serum calcium concentration [ Time Frame: 12 weeks ]Change in serum calcium concentration following dose administration at week 12
- ECOG PS [ Time Frame: 3 months ]ECOG Performance status
- Overall survival [ Time Frame: 2 years ]Time from randomization to death
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Male |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379012
| Russian Federation | |
| 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 | |
| Responsible Party: | Kidney Cancer Research Bureau |
| ClinicalTrials.gov Identifier: | NCT03379012 |
| Other Study ID Numbers: |
KCRB08022016 |
| First Posted: | December 20, 2017 Key Record Dates |
| Last Update Posted: | October 22, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Sunitinib Methyltestosterone Testosterone |
Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |