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RECRUITING

NCT05254171

PHASE2/PHASE3

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

Sponsor: Panbela Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2022-08-08

Completion Date

2027-01-01

Last Updated

2024-11-06

Healthy Volunteers

Conditions

Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Stage IV

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

Inclusion Criteria: * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. * Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard treatment with gemcitabine and nab-paclitaxel. Subjects who have had planned or prior surgery, such as a Whipple procedure, with or without neo-adjuvant/or adjuvant chemotherapy may be included. * Life expectancy ≥ 3 months. * Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan by RECIST v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. * Adult, age ≥ 18 years, male or female. * Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception from 2 weeks before the first administration of SBP-101 until 6 months after the last administration of study drug (i.e., last dose of any of the three drugs in the regimen). Female subjects are considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, all with surgery at least one month before dosing). * Adequate bone marrow, hepatic and renal function as outlined in protocol. * QTc interval ≤ 470 ms (for women) and ≤ 450 ms (for men) on the ECG at baseline calculated by either the Fridericia or Framingham formula. * Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required. Exclusion Criteria: * When results of germline or somatic testing done prior to screening are known, subjects known to have mutations of the BRCA 1/2 (Breast Cancer gene) are excluded. * Concomitant metformin administration. Diabetic subjects on treatment with metformin, or any other derivative thereof, must discontinue it at least 5 days prior to C1D1 and not take metformin while on study (other diabetic medications are allowed). * Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia \[-6.0 diopters or approximately 20/500\], eye surgery \<6 months prior to C1D1, or history of a severe eye injury. Subjects with findings of retinopathy on baseline ophthalmology exams will be excluded. * Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded. * Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance. * Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma. * Symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required. * Serum albumin \< 30 g/L (3.0 g/dL). * Deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism (PE), or other thromboembolic event that occurs during screening. * Presence of known active bacterial, fungal, or viral infection requiring systemic therapy. * Known active infection with human immunodeficiency virus (HIV), hepatitis B or C. * Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction. * Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV. * Pregnant or lactating. * Major surgery within 4 weeks prior to the start of study drug treatment, without complete recovery. * Known hypersensitivity to any component of study treatments. * Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug. * Any history of hydroxychloroquine use (Plaquenil® and other brand names).

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (93)