Colorectal Neoplasms Clinical Trial
Official title:
A Phase IB/IIA, Single-centered Study of the Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasia
The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe and tolerated in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At level of MTD, additional patients will be included aimed for assessing the efficacy profile in these neoplasia entities.
The IMP OXY111A counteracts hypoxia-induced tumor aggressiveness showing decreased tumor
burden and increased survival in five different animal solid tumor models both applied as
monotherapy and increased beneficial effects when followed by standard chemotherapy. The
unique ability of the IMP counteract hypoxic tumor behaviour along with its non-toxic side
effects tested both in animals and healthy volunteers is of outmost interest to explore in
patients with solid tumors.
The study seeks primarily to determine the safety and tolerability of OXY111A in patients
with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as
measured by exploring the MTD in a conservative 3+3 dose escalation schedule. The window for
DLT assessment is from first dose of study drug until first dose of standard of care
chemotherapy or 10 days following completion of last dose of study drug (whichever is
shorter in duration). Additionally, we will assess efficacy of OXY111A on decreasing tumor
volume, metabolic activity, as well as circulatory tumor and angiogenic markers.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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