Trials / Recruiting
RecruitingNCT05254171
Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
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
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Panbela Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This trial will enroll approximately 600 patients to evaluate the effect of SBP-101 on Overall Survival when administered with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel and a placebo. Secondary endpoints include Progression-free survival, radiologic responses to treatment, and Quality of Life measures. An independent, external Data Safety Monitoring Board (DSMB) will monitor safety and efficacy and a planned futility analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-08-08
- Primary completion
- 2026-08-29
- Completion
- 2027-01-01
- First posted
- 2022-02-24
- Last updated
- 2024-11-06
Locations
93 sites across 10 countries: United States, Australia, Austria, Belgium, France, Germany, Italy, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05254171. Inclusion in this directory is not an endorsement.