Clinical Trials

Sorafenib Tosylate and Hypoxia-Activated Prodrug TH-302 in Treating Patients With Advanced Kidney Cancer or Liver Cancer That Cannot Be Removed By Surgery

Location:

Rochester, MN, Scottsdale and Phoenix, AZ

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES: Primary - To determine the maximum-tolerated dose (MTD) and recommended Phase II dosing (RP2D) for the combination of sorafenib tosylate and hypoxia-activated prodrug TH-302 (TH-320) in patients with hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC; non-HCC) advanced solid tumors. (Phase I) - To evaluate the overall response rate (RR) determined based on modified RECIST criteria (Lencioni and Llovet 2010) in patients with advanced HCC receiving sorafenib tosylate with TH-302. (Phase II) Secondary - To characterize overall toxicity profile of sorafenib tosylate + TH-302 within patients with HCC and RCC (non-HCC) advanced solid tumors. (Phase I) - To characterize the responses of sorafenib tosylate + TH-302 within patients with HCC and RCC (non-HCC) advanced solid tumors. (Phase I) - To assess the adverse events (AEs) profile and safety profile of sorafenib tosylate in combination with TH-302 in patients with advanced HCC. (Phase II) - To estimate the overall response rate based on standard RECIST criteria in the study population. (Phase II) - To estimate the duration of response based on modified (standard) RECIST criteria in the study population. (Phase II) - To estimate the progression free survival (PFS) in the study population. (Phase II) - To estimate the overall survival (OS) in the study population. (Phase II) - To estimate the alpha-fetoprotein (AFP) response rate (defined as > 20% decrease of AFP from baseline) in the study population. (Phase II) OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II study. Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-28 and hypoxia-activated prodrug TH-302 IV over 30 minutes on days 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Some patients undergo blood sample collection periodically during study for alpha-fetoprotein analysis. After completion of study treatment, patients are followed up for 3 years.

Last updated: 02/20/2013

NCT ID:

NCT01497444