Last updated on July 2019

RX-3117: A Phase 1/2 Open-Label, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of RX-3117 in Combination with Abraxane® in Subjects with Metastatic Pancreatic Cancer


Brief description of study

1.1 Phase 1 Primary

  • To evaluate the safety and tolerability of RX-3117 in combination with Abraxane® in subjects with metastatic pancreatic cancer
  • To determine the Recommended Phase 2 Dose (RP2D) of RX-3117 when administered orally in combination with Abraxane® to subjects with metastatic pancreatic cancer

1.2 Phase 1 Secondary

  • To determine the pharmacokinetic (PK) profiles of RX-3117 and Abraxane® on Day 1 (single dose) and Day 15 (steady-state) in Cycle 1
  • To evaluate the antitumor activity of RX-3117 in combination with Abraxane®

1.3 Phase 1 Exploratory

  • To investigate predictive and pharmacodynamic blood or tumor biomarkers suggested from nonclinical studies/literatures which may be predictive of response or resistance to RX-3117 treatment

1.4 Phase 2 Primary

  • To estimate the antitumor activity of RX-3117 in combination with Abraxane® as first-line therapy in subjects with metastatic pancreatic cancer

1.5 Phase 2 Secondary

  • To assess additional measures of antitumor activity
  • To characterize the safety profile of RX-3117 in combination with Abraxane®
  • To evaluate the PK of RX-3117 and Abraxane® at the recommended Phase 2 dose (RP2D)

1.6 Phase 2 Exploratory

  • To investigate the effect of RX-3117 in combination with Abraxane® on potential cellular or molecular biomarkers in blood or tumor samples
  • To evaluate the change in tumor burden response
  • To evaluate the effect on Quality of Life (QOL)

Clinical Study Identifier: TX208034

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Baptist Health Lexington Clinical Research Center

1740 Nicholasville Road Lexington, KY USA
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