Solid Tumors Clinical Trial
Official title:
Phase I Trial of Oral 5-azacitidine With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma
The purpose of this study is to determine whether 5-azacitidine in combination with romidepsin cancer are effective in the treatment of advanced solid tumors.
This is a two part, single-institution, open-label, Phase I dose-escalation study of oral
5-azacitidine in combination with intravenous (IV) romidepsin. Part 1 of the study is a
traditional 3 + 3 dose escalation study designed to evaluate the maximum tolerated dose
(MTD), dose limiting toxicities (DLTs), safety, pharmacokinetic (PK) profiles, and
pharmacodynamic profiles of increasing doses of orally administered 5-azacitidine in
combination with a constant dose of IV romidepsin. Part 2 is an expansion cohort study for
the preliminary evaluation of efficacy in the treatment of virally mediated cancers and
liposarcoma once the MTD has been determined. PK and PD data will also be collected for
these subjects.
- Plasma samples will be obtained, prior and during treatment, to assess the methylation
status of free tumor DNA circulating in the blood
- Archival tissue will be obtained on all participants for future correlative studies,
such as baseline gene expression, methylation patterns.
- Participants with accessible, biopsiable tumors will also undergo pre-treatment and
post-treatment (~cycle 2D1) biopsies for correlative studies in the expansion cohort.
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|---|---|---|---|
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