Pancreatic Adenocarcinoma Clinical Trial
Official title:
Phase Ib Multicenter, Cohort Dose Escalation Trial to Determine the Safety, Tolerance and Preliminary Antineoplastic Activity of Gemcitabine Administered in Combination With Continuous Intravenous Doses of PRI-724, a CBP/ β- Catenin Inhibitor, to Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Eligible for Second-Line Therapy After Failing First-Line Therapy With FOLFIRINOX (or FOLFOX)
Laboratory studies suggest that the study drug may stop cancer cells from growing by
affecting an interaction between proteins in the cells referred to as cAMP-response
element-binding protein and ß-catenin.
The purpose of this research study is to determine the highest safe dose of study drug that
may be used when it is given together with a chemotherapy drug to patients with cancer of the
pancreas.
PRI-724 is a small molecule antagonist that binds to the co-activator CBP thereby
specifically inhibiting the subset of Wnt/β-catenin-driven genes that are up-regulated in
cancer cells. PRI-724 is being developed as a potential antineoplastic agent.
Purpose:
To determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated
dose (MTD) of sequential escalating doses per cohort of PRI-724 administered in combination
with gemcitabine to patients with adenocarcinoma of the pancreas that is locally advanced,
metastatic, or otherwise inoperable, who are candidates for second-line therapy after failing
first-line therapy with FOLFIRINOX (i.e., folinic acid [leucovorin], fluorouracil,
irinotecan, oxaliplatin)
- PRI-724: 320, 640, 905 mg/m2/day, continuous intravenous (CIV) infusion over 24 h, daily
× 7 days, 1 week on with 1 week recovery × 2 (4 weeks equals 1 cycle)
- Gemcitabine: 1000 mg/m2 IV over 30 minutes; 3 weeks on with 1 week recovery (4 weeks
equals 1 cycle)
Patients with documented, measurable or evaluable adenocarcinoma of the pancreas that is
locally advanced, metastatic, or otherwise inoperable, who are candidates for second-line
therapy after failing first-line therapy with FOLFIRINOX, will be entered into this phase 1b,
multicenter, open-label, non-randomized, dose-escalation per cohort study. The trial is
designed to evaluate the safety, tolerability, DLT(s), and MTD of escalating doses of
PRI-724, a CBP/ β- catenin inhibitor, when administered in combination with a standard dose
of gemcitabine. Correlative studies include characterization of the PK profiles of PRI-724
and gemcitabine, evaluation of the utility of potential PD markers of PRI-724 activity, as
well as preliminary assessment of the antineoplastic activity of PRI-724 plus gemcitabine in
this patient population.
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