Pancreatic Cancer Clinical Trial
Official title:
A Phase 1 Study of VS-4718, a Focal Adhesion Kinase Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Subjects With Advanced Cancer
The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to determine a recommended Phase 2 dose (RP2D) for further development of this combination in subjects with untreated advanced pancreatic cancer.
The study is comprised of 2 sequential parts: Part A (Dose Escalation of VS-4718) in subjects
with advanced cancer and Part B (Expansion) in subjects with untreated advanced pancreatic
cancer.
Up to 60 evaluable subjects (i.e., subjects who complete at least 1 cycle (28 days) of
therapy) will be enrolled, assuming that:
1. Part A: The maximum sample size will be 6 subjects up to 4 dose levels (exclusive of
replacement subjects). However, additional subjects may be added if exploration of
intermediate dose level(s) of VS 4718 is warranted. The starting dose of VS-4718 will be
200mg BID.
2. Part B: Up to 36 additional subjects may be enrolled at the RP2D. These subjects will be
randomized at a 1:1 ratio to 1 of 2 treatment cohorts:
- Cohort 1: IV treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes
on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8,
and 15) and oral VS 4718 BID continuously starting on Day 1 of Cycle 1
- Cohort 2: IV treatment for the first 2 cycles, followed by IV treatment and oral
VS-4718 BID continuously starting on Day 1 of Cycle 3
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