Clinical Trial: SLM + Axitinib for Clear Cell RCC

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Ce

Brief Summary: This is a Phase 1 trial for safety and preliminary efficacy of the combination of axitinib and selenomethionine (SLM) for adult patients with advanced metastatic clear cell renal cell carcinoma (CCRCC). This will be a two part study consisting of a dose escalation and expansion study.

Detailed Summary:

This is a Phase 1 trial for safety and preliminary efficacy of the combination of axitinib and selenomethionine (SLM) for adult patients with advanced metastatic clear cell renal cell carcinoma (CCRCC). This will be a two part study consisting of a dose escalation and expansion study.

Dose-Escalation Part 1 (6-12 patients) : SLM will be given twice daily for 14 days followed by SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.

Expansion Part 2: In this phase (approximately 19 patients), will be treated at the maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1. It will be 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 in patients with advanced renal cell carcinoma. Treatment will continue until disease progression or unacceptable toxicity.


Sponsor: University of Iowa

Current Primary Outcome: Incidence of adverse events (AE) per CTCAE 4.03 [ Time Frame: After 2 cycles (28 days) ]

The AEs will be summarized and classified by body system and by treatment group. The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tumor Response rate as assessed by RECIST v.1.1 [ Time Frame: After 2 cycles (28 days) ]
  • Progression free survival (PFS) [ Time Frame: 14 months ]
  • Overall survival (OS) [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: University of Iowa

Dates:
Date Received: August 17, 2015
Date Started: January 2016
Date Completion: September 2019
Last Updated: November 7, 2016
Last Verified: November 2016