RecruitingPhase 2Phase 3NCT05254171

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

Sponsor

Panbela Therapeutics, Inc.

Enrollment

600 participants

Start Date

Aug 8, 2022

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Stage IV Pancreatic Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new investigational drug called SBP-101 to the standard chemotherapy regimen (gemcitabine and nab-paclitaxel) improves outcomes for patients with metastatic pancreatic cancer. SBP-101 works differently from traditional chemotherapy and may help make standard drugs more effective. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic pancreatic ductal adenocarcinoma (the most common type) - You have not yet received treatment for your metastatic disease - Your metastatic disease was diagnosed within the past 3 months - You are in good physical condition (ECOG 0 or 1) with a life expectancy of at least 3 months - Your cancer has measurable areas on CT or MRI scans **You may NOT be eligible if...** - You have already received treatment for metastatic pancreatic cancer - Your cancer is not the ductal adenocarcinoma type - You have significant heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSBP-101

small molecule polyamine metabolic inhibitor for subcutaneous injection

DRUGNab-paclitaxel

paclitaxel protein-bound particles for injectable suspension

DRUGGemcitabine

gemcitabine for injection

OTHERPlacebo

Normal Saline

Locations(93)

Genesis Cancer and Blood Institute (SCRI)

Hot Springs, Arkansas, United States

Providence Medical Foundation

Fullerton, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Henry Ford Health System

Detroit, Michigan, United States

CentraCare Health

Saint Cloud, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Mark H Zangmeister Center - SCRI - PPDS

Columbus, Ohio, United States

Tennessee Oncology NASH - SCRI - PPDS

Nashville, Tennessee, United States

HOPE Cancer Center of East Texas

Tyler, Texas, United States

Medical Oncology Associates - Spokane

Spokane, Washington, United States

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Canberra Region Cancer Centre

Garran, Australia Capital Territory, Australia

The Tweed Hospital

Tweed Heads, New South Wales, Australia

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Austin Hospital

Heidelberg, Victoria, Australia

St John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Klinikum Klagenfurt Am Woerthersee

Klagenfurt, Carinthia, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Lower Austria, Austria

Ordensklinikum Linz, Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H

Linz, Upper Austria, Austria

Pyhrn-Eisenwurzen Klinikum Steyr

Steyr, Upper Austria, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, Austria

Landeskrankenhaus Feldkirch

Rankweil, Vorarlberg, Austria

Kepler Universitätsklinikum Linz

Linz, Austria

Salzburg Cancer Research Institute

Salzburg, Austria

A.ö. Krankenhaus der Barmherzigen Brüder

Wein, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

Imelda VZW

Bonheiden, Antwerpen, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgique, Belgium

Hôpital de Jolimont

La Louvière, Hainaut, Belgium

Centre Hospitalier de l'Ardenne

Libramont, Luxembourg, Belgium

CHU UCL Namur asbl - Site Godinne

Yvoir, Namur, Belgium

Onze-Lieve-Vrouwziekenhuis

Aalst, Oost-Vlaanderen, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

Grand Hopital de Charleroi asbl

Charleroi, Belgium

UZ Leuven

Leuven, Belgium

CHU de Liège

Liège, Belgium

Hopitaux de La Timone

Marseille, Bouches-du-Rhône, France

Centre François Baclesse

Caen, Calvados, France

Hopital Jean Minjoz

Besançon, Doubs, France

Hôpital de Rangueil

Toulouse, Haute-Garonne, France

EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

Rennes, Ille-et-Vilaine, France

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Asklepios Klinik Altona

Hamburg, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Klinikum Weiden

Weiden, Germany

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Apulia, Italy

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

Meldola, Emilia-Romagna, Italy

Azienda Unita Sanita Locale di Reggio Emilia IRCCS

Reggio Emilia, Emilia-Romagna, Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, Italy

Instituto Europeo Di Oncologia

Milan, Lombardy, Italy

Ospedale degli Infermi

Candiolo, Piedmont, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Ospedale Santa Maria Della Misericordia Di Perugia

Terni, Umbria, Italy

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Venito, Italy

Fondazione IRCCS Policlinico San Matteo di Pavia-Vialle Camillo Golgi 19

Pavia, Italy

National Cancer Center

Seoul, Gyeonggido, South Korea

CHA Bundang Medical Center, CHA University

Seoul, Gyeonggido, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, Seoul Teugbyeolsi, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Asan Medical Center - PPDS

Seoul, South Korea

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Jaen

Jaén, Jaen, Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, Madrid, Spain

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, Madrid, Communidad Delaware, Spain

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain

Clinica Universidad Navarra

Pamplona, Navarre, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Hospital Universitario A Coruña

A Coruña, Spain

Hospital Universitario de Badajoz

Badajoz, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain

Institut Catala d'Oncologia Girona

Girona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

MD Anderson Cancer Center Madrid - España

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz - PPDS

Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Aberdeen Royal Infirmary - PPDS

Aberdeen, Aberdeen City, United Kingdom

Hammersmith Hospital

London, City of London, United Kingdom

Derriford Hospital

Plympton, Devon, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05254171

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