MK-0646 and Gemcitabine +/- Erlotinib for Patients With Advanced Pancreatic Cancer
Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
Objectives:
Primary Objectives:
- Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with
gemcitabine or gemcitabine plus erlotinib and recommended phase II dose.
- Phase II:
- Assess progression-free survival (PFS) with a) gemcitabine plus MK-0646 b)
gemcitabine plus erlotinib plus MK-0646 and c) gemcitabine plus erlotinib.
- Explore IGF1 tissue level as a predictive biomarker for MK-0646 therapy in phase II
expansion cohort.
Secondary Objectives:
- Assess overall response rate (ORR), treatment toxicity, and overall survival (OS) with
the addition of MK-0646 to gemcitabine or gemcitabine plus erlotinib.
- Correlate PFS and OS with IGF-1, IGFBP-3 levels and the expression of p-IRS, IGF-1R, EMT
biomarkers, Akt, Erk, mTOR, and PI13k in tumor cells.
- To assess the incidence of single nucleotide polymorphisms of the IgF1R pathway related
genes (IGF1, IGF1R, IRS1 and IRS2). These genotypes will be correlated with the clinical
endpoints of this study, including OS, ORR and PFS.