CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Selenomethionine (SLM) +4 moredrug
Likely dose
Selenomethionine (SLM) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02535533
NCT02535533Phase 2Completed
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A Therapeutic Trial for Safety and Preliminary Efficacy of the Combination of Axitinib and Seleniomethionine (SLM) for Adult Patients With Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC)

Mohammed Milhem·interventional·Posted Aug 28, 2015·Updated May 6, 2026

In Brief

A Phase 2 clinical trial evaluating Selenomethionine (SLM) and Axitinib for Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC). Completed, enrolled 45 participants across 1 site.

Detailed Summary

This phase I trial studies the side effects and best dose of L-selenomethionine when given together with axitinib in treating patients with clear cell renal cell carcinoma that has spread from the primary site (place where it started) to other places in the body and usually cannot be cured or controlled with treatment (advanced metastatic). L-selenomethionine may stop the growth of tumor cells by blocking the growth of new blood vessels necessary for tumor growth. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving L-selenomethionine together with axitinib may be a better treatment for advanced metastatic clear cell renal cell carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC)
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 28, 2015
Enrollment StartJan 1, 2016
Primary CompletionAug 22, 2023
Study CompletionApr 4, 2025
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 10.8 years ago

Interventions

Selenomethionine (SLM)drug

SLM administrated orally twice daily for 14 days followed by SLM once daily in combination with Axitinib 5 mg twice daily with titration according to package insert

Axitinibdrug

Following SLM administrated orally twice daily for 14 days, SLM once daily in combination with Axitinib 5 mg twice daily with titration according to package insert

Selenomethionine (SLM)drug

Maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1 (4000 mcg SLM) given orally twice daily for 14 days, followed by SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert

Axitinibdrug

Following maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1 (4000 mcg SLM) given orally twice daily for 14 days, SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert

Selenomethionine (SLM)drug

Pilot Phase - Dosing will begin at dose level 3 (4000, 5000 or 6000 mcg SLM calculated based on patients' BSA). SLM will be given orally twice daily for 14 days