At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
- ✓Treatment-naïve for metastatic disease; diagnosed within past 3 months
- ✓Prior surgery (e.g., Whipple) with or without neo-adjuvant/adjuvant chemotherapy allowed
- ✓Expected to receive standard treatment with gemcitabine and nab-paclitaxel
- ✕Known BRCA1/2 mutations
- ✕Concomitant metformin administration; must discontinue ≥5 days prior to C1D1
- ✕History of retinopathy or risk for retinal detachment (personal/family history, extreme myopia ≤-6.0 diopters, eye surgery <6 months, severe eye injury)
- ✕Retinopathy findings on baseline ophthalmology exam
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SBP-101, Nab-paclitaxel, and 2 other interventions for Pancreatic Cancer Metastatic and 2 related conditions. Currently recruiting, targeting 600 participants across 93 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
small molecule polyamine metabolic inhibitor for subcutaneous injection
paclitaxel protein-bound particles for injectable suspension
gemcitabine for injection
Normal Saline