Advanced Solid Tumors Clinical Trial
Official title:
An Exploratory Biomarker Study of ARQ 501 in Patients With Advanced Solid Tumors
This study is designed to evaluate the response of several biomarkers in patients treated with ARQ 501. The results of the study may help the sponsor understand the effect of the study drug on these biomarkers and their respective role in cancer growth control.
ARQ 501 is an investigational anticancer agent that consists of a fully synthetic small
molecule version of β-lapachone (3,4-dihydro-2,2-dimethyl-2H-naphtho[1,2-b]pyran-5,6-dione)
in a stable formulation for intravenous (IV) administration. ARQ 501 selectively induces
apoptosis in cancer cells by the direct activation of the cellular checkpoints without
damaging deoxyribonucleic acid (DNA) or microtubules. This therapeutic approach is known as
Activated Checkpoint Therapy (ACT)sm. ACTsm is a novel strategy for treating and preventing
cancers. Cell cycle checkpoints constitute an internal surveillance system that detects
cellular, especially genetic, damage and either allows the cells to repair the damage, or
induces apoptosis when damage is not repairable. Cancer cells are selectively eliminated
upon checkpoint activation due to presence of irreparable DNA damage. It is believed that
the rapid and selective induction of apoptosis in cancer cells by ARQ 501 is caused by a
correspondingly rapid and sustained increase of the pro-apoptotic protein E2F1.
Preclinical studies have shown that exposure to ARQ 501 results in the activation or
inactivation of a panel of 5 biomarkers. Time course changes in human tumor xenograft
biomakers in athymic mice after exposure to ARQ 501 can be classified into 3 biomarker
groups: those that changed shortly after exposure and returned to normal within 24 hours;
those that changed shortly after exposure and remained for 24 hours or longer; and those
that changed after 24 hours or later.
The primary objective is to evaluate the response of biomarkers in patients treated with ARQ
501. The exploratory study will help to illuminate the pharmacodynamics of these biomarkers,
their roles in the cancer growth control, and their potential predictive or prognostic
values for the disease and treatment of ARQ 501 in humans.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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