Solid Tumors Clinical Trial
Official title:
A Phase 1 Dose Escalation Safety/Tolerance Study of PPI-2458 in Subjects With Non-Hodgkin’s Lymphoma and Solid Tumors
The purpose of this multi-center, open-label, escalating dose study is to assess the safety and tolerability of PPI-2458 in subjects with Non-Hodgkin's Lymphoma (NHL)and solid tumors. Subjects will be treated every other day (QOD) with PPI-2458 while being monitored closely for adverse events.
The study will first determine the dose level that maximally inhibits MetAP2 in white blood
cells (WBC). Once this dose level is reached, the study will proceed into the next cohort
(dose level) to investigate the dose level that maximally inhibits MetAP2 in tumor tissue
biopsies. Free MetAP2 levels (WBC and/or tumor tissue) will be analyzed during the first
cycle (28 days) of treatment. Cohorts are expected to enroll every two cycles until the
maximum tolerated dose (MTD)is determined.
After the Initial Treatment Phase of two treatment cycles of PPI-2458, subjects may continue
into a Continuous Treatment Phase at the discretion of the Investigator. In order to be
eligible for the Continuous Treatment Phase of the protocol, subjects must have received
some benefit (e.g., stable disease) as assessed by the Investigator within the Initial
Treatment Phase and must continue to meet inclusion and exclusion criteria.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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