Safety and Efficacy Study of PRI-724 in Subjects With Advanced Solid Tumors
Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have
advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that
cancer cells need to grow and spread(metastasize).
Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating doses
(per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen. PRI-724
dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.
Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts
with CRC will be treated with escalating doses (per cohort) of PRI-724 administered in
combination with a modified regimen of FOLFOX6 (mFOLFOX 6, standardized doses and schedule)
in order to identify the MTD of this combined regimen. Up to 2 dose levels of PRI-724 are to
be examined (640 and 905 mg/m2/day, CIV infusion over 24 hours × 7 days), with potential to
evaluate a previously unexamined intermediate dose, if indicated, to more fully characterize
tolerability. The MTD cohort (or maximum dose to be studied) will be expanded up to 12
patients.