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Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

NCT05254171 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-11-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Panbela Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael J Walker, MD · Panbela Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2026-08-29
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254171 on ClinicalTrials.gov