A Phase 1b/2, Dose-escalation, Randomized, Multicenter Study of Maintenance Ivaltinostat plus Capecitabine or Capecitabine Monotherapy in Patients with Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on First Line FOLFIRINOX Chemotherapy
Objective
Phase 1b: Primary-To determine the safety, tolerability, and RP2D of ivaltinostat in combination with capecitabine. Secondary- To determine the pharmacokinetic (PK) profile of ivaltinostat and capecitabine administered in combination. To determine the efficacy of ivaltinostat in combination with capecitabine.
Phase 2: Primary- To determine the efficacy, as measured by Investigator-adjudicated PFS, of ivaltinostat in combination with capecitabine versus capecitabine monotherapy for PDAC maintenance treatment after disease response or stability with FOLFIRINOX chemotherapy regimen. Secondary-To determine the efficacy of ivaltinostat in combination with capecitabine versus capecitabine monotherapy. To further assess the safety and tolerability of ivaltinostat in combination with capecitabine versus capecitabine monotherapy. To further evaluate the PK profile of ivaltinostat and capecitabine in combination.
