A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma

Summary

The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  SBP-101

  small molecule polyamine metabolic inhibitor for subcutaneous injection

• Drug
  Nab-paclitaxel

  paclitaxel protein-bound particles for injectable suspension

• Drug
  Gemcitabine

  gemcitabine for injection

• Other
  Placebo

  Normal Saline

Locations (93)