Liver Cancer Clinical Trial
Official title:
Study of Sorafenib + TH-302: Phase I in Advanced Renal Cell Carcinoma (RCC) and Advanced Hepatocellular Carcinoma (HCC) and Phase II in 1st Line Advanced HCC
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in
chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells.
PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib
tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in
treating patients with advanced kidney cancer or liver cancer that cannot be removed by
surgery.
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-302) 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.
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