NCT02535533 - SLM + Axitinib for Clear Cell RCC | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

August 22, 2023

Study Completion Date

April 4, 2025

Conditions

Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC)

Interventions

DRUG

Selenomethionine (SLM)

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

DRUG

Axitinib

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

DRUG

Selenomethionine (SLM)

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

DRUG

Axitinib

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

DRUG

Selenomethionine (SLM)

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

Trial Locations (1)

52242

University of Iowa Hospitals and Clinics, Iowa City