AzTrials
AzTrials

Pancreatic Cancer MetastaticPhase 2/3ASPIRENCT05254171

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

A Phase 2/3 study testing SBP-101, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer Metastatic and Pancreatic Ductal Adenocarcinoma, run by Panbela Therapeutics, Inc. at 93 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SBP-101, Nab-paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
93 sitesin 10 countries
Study dates
8 Aug 2022to 1 Jan 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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).

Trial locations and contacts

93 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Rachel Bragg, MPH contact

952-479-1196

rbragg@panbela.com

Tammy Groene contact

952-479-1196

tgroene@panbela.com

93 sites in 10 countries

Spain24 sites, 23 recruiting

  • Hospital Universitario A Coruña

    A Coruña, 15006

    Active, not recruiting

  • Hospital Universitario de Badajoz

    Badajoz, 06011

    Veronica Serrano Pecos, MD, +34924218040, veronica.serrano@salud-juntaex.es

    Recruiting

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Laura Layos, MD, +34934978925, llayos@iconcologia.net

    Recruiting

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903

    Alberto Muñoz Llarena, MD, +34946006399, ALBERTO.MUNOZLLARENA@osakidetza.eus

    Recruiting

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, Madrid, 08041

    Paula Cerda Serda, MD, +34935565638, pcerda@santpau.cat

    Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

    Teresa Macarulla Mercade, MD, +34934894301, tmacarulla@vhio.net

    Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908

    Berta Laquente Sáez, MD, +34932607744, blaquente@iconcologia.net

    Recruiting

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120

    Miguel Marin Vera, MD, +34968369516, miguelmarin75@hotmail.com

    Recruiting

  • Institut Catala d'Oncologia Girona

    Girona, 17007

    Adelaida García-Velasco, MD, PhD, +34972225828, agvelasco@iconcologia.net

    Recruiting

  • Hospital Universitario de Jaen

    Jaén, Jaen, 23007

    Natalia Luque Caro, MD, +34953220306, nluquecilla@gmail.com

    Recruiting

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, Madrid, Communidad Delaware, 28050

    Antonio Cubillo Gracián, MD, +34917567850, acubillo@hmhospitales.com

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Andres Muñoz Martin, MD, PhD, +34914269394, andresmunmar@hotmail.com

    Recruiting

  • MD Anderson Cancer Center Madrid - España

    Madrid, 28033

    Jose Ignacio Martin Valades, +348888888888, jose.martinv@mdanderson.es

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Carmen Guillen Ponce, MD, +34913368835, carmenguillenponce@gmail.com

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Angela Lamarca, +34915504800 ext. 2299, angela.lamarca@quironsalud.es

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Angela Lamarca Lete, MD, +34915504800 ext. 2299, angela.lamarca@quironsalud.es

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Rocio Garcia Carbonero, PhD, +34913908923, rgcarbonero@gmail.com

    Recruiting

  • Hospital Universitario La Paz - PPDS

    Madrid, 28048

    Jaime Feliu, MD, +34917277516, jaime.feliu@salud.madrid.org

    Recruiting

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010

    Sabrina López, +34951308129, sabrina.lopez.eecc@gmail.com

    Recruiting

  • Clinica Universidad Navarra

    Pamplona, Navarre, 31008

    Mariano Ponz-Sarvisé, MD, PhD, +34948255400, mponz@unav.es

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Ruth Vera Garcia, MD, +34848422576, ruth.vera.garcia@cfnavarra.es

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Fernando Rivera Herrero Sr., MD, PhD, +34942202525, fernando.rivera@scsalud.es

    Recruiting

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

    Esperanza Muñoz, espe.m.garcia@gmail.com

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41071

    Rosario Carrillo, MD, +34955926578, roscarr81@gmail.com

    Recruiting

Other trials in Spain

United States14 sites, 9 recruiting

  • Mark H Zangmeister Center - SCRI - PPDS

    Columbus, Ohio, 43219

    Terminated

  • Henry Ford Health System

    Detroit, Michigan, 48202-2643

    Philip Philip, MD, 313-576-8728, pphilip1@hfhs.org

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Jagruti Khandhadia, 714-446-5900 ext. 2277, jagruti.khandhadia@providence.org

    Recruiting

  • Genesis Cancer and Blood Institute (SCRI)

    Hot Springs, Arkansas, 71913

    Withdrawn

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Medical College of Wisconsin Cancer Center Clinical Trials Office, 414-805-8900, cccto@mcw.edu

    Mandana Kamgar, Study Principle Investigator

    Recruiting

  • Tennessee Oncology NASH - SCRI - PPDS

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06519

    Jill Lacy, MD, 203-737-1600, jill.lacy@yale.edu

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Navigator Office Nurse, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Chris LeFeber, 585-275-0407, chris_lefeber@urmc.rochester.edu

    Recruiting

  • CentraCare Health

    Saint Cloud, Minnesota, 56303

    Withdrawn

  • Medical Oncology Associates - Spokane

    Spokane, Washington, 99208

    Monika Chaudhry, PhD, 509-462-2273 ext. 418, monika.chaudhry@aoncology.com

    Recruiting

  • MultiCare Regional Cancer Center - Tacoma

    Tacoma, Washington, 98405

    Samantha Blake, 253-572-7320, Samantha.Blake@multicare.org

    Recruiting

  • HOPE Cancer Center of East Texas

    Tyler, Texas, 75701

    Grace Loredo, 903-592-6152 ext. 286, grace.loredo@uthct.edu

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Active, not recruiting

Other trials in United States

Belgium11 sites, 11 recruiting

  • Onze-Lieve-Vrouwziekenhuis

    Aalst, Oost-Vlaanderen, 9300

    Esther Dujardin, +3253728716, esther.dujardin@olvz-aalst.be

    Recruiting

  • Imelda VZW

    Bonheiden, Antwerpen, 2820

    Doreen Iwens, +3215504710, doreen.iwens@imelda.be

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgique

    Tuon Le, +3227644213, trong.le@saintluc.uclouvain.be

    Not yet recruiting

  • Grand Hopital de Charleroi asbl

    Charleroi, 6000

    Matthias Papier, +3271104767, matthias.papier@ghdc.be

    Recruiting

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

    Tine Derre, +3293325125, tine.derre@uzgent.be

    Recruiting

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

    Fien Verplancke, +3256633338, fien.verplancke@azgroeninge.be

    Recruiting

  • Hôpital de Jolimont

    La Louvière, Hainaut, 7100

    Alexandre Dermine, +3264231804, alexandre.dermine@jolimont.be

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Ramy Slimane, +3216338670, ramy.slimane@uzleuven.be

    Recruiting

  • Centre Hospitalier de l'Ardenne

    Libramont, Luxembourg, 6800

    Celine Lewis, +3263552197, celine.louis@vivalia.be

    Recruiting

  • CHU de Liège

    Liège, 4000

    Joelle Collignon, MD, +3243667801, joelle.collignon@chuliege.be

    Recruiting

  • CHU UCL Namur asbl - Site Godinne

    Yvoir, Namur, 5530

    Géraldine Mineur, +3281423853, geraldine.mineur@chuuclnamur.uclouvain.be

    Recruiting

Other trials in Belgium

Austria10 sites, 8 recruiting

  • Klinikum Klagenfurt Am Woerthersee

    Klagenfurt, Carinthia, 9020

    Wolfgang Eisterer, MD, +4346353834603, wolfgang.eisterer@kabeg.at

    Recruiting

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

    Linz, Upper Austria, 4020

    Angela Plasser, +4373276774319, angela.plasser@ordensklinikum.at

    Not yet recruiting

  • Kepler Universitätsklinikum Linz

    Linz, 4021

    Isabella Rauscher, +4357680836204, isabella.rauscher@kepleruniklinikum.at

    Recruiting

  • Landeskrankenhaus Feldkirch

    Rankweil, Vorarlberg, 6830

    Thomas Winder, PhD, +4355223032300, thomas.winder@lkhf.at

    Recruiting

  • Salzburg Cancer Research Institute

    Salzburg, 5020

    Active, not recruiting

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

    Petra Pichler, MD, +43274290042142, petra.pichler@stpoelten.lknoe.at

    Recruiting

  • Pyhrn-Eisenwurzen Klinikum Steyr

    Steyr, Upper Austria, 4400

    Withdrawn

  • A.ö. Krankenhaus der Barmherzigen Brüder

    Wein, 1020

    Johannes Meran, MD, +431211212105, johannes.meran@bbwien.at

    Recruiting

  • Klinikum Wels-Grieskirchen GmbH

    Wels, Upper Austria, 4600

    Birgit Reisinger-Eisenrauch, +4372424153452, birgit.reisinger-eisenrauch@klinikum-wegr.at

    Recruiting

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700

    Klaus Loidolt, +432622900423511, klaus.loidolt@wienerneustadt.lknoe.at

    Recruiting

Other trials in Austria

Italy10 sites, 9 recruiting

  • Ospedale degli Infermi

    Candiolo, Piedmont, 10060

    Completed

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

    Meldola, Emilia-Romagna, 47014

    Giovanni Luca Frassineti, MD, +390543739100, luca.frassineti@irst.emr.it

    Recruiting

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132

    Michele Reni, MD, +390226437644, reni.michele@hsr.it

    Recruiting

  • Instituto Europeo Di Oncologia

    Milan, Lombardy, 20141

    Chiara Alessandra Cella, MD, +390257489258, chiaraalessandra.cella@ieo.it

    Recruiting

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

    Pavia, 27100

    Anna Pagani, +390382501671, a.pagani@smatteo.pv.it

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126

    Caterina Vivaldi, MD, +39050992455, caterinavivaldi@gmail.com

    Recruiting

  • Azienda Unita Sanita Locale di Reggio Emilia IRCCS

    Reggio Emilia, Emilia-Romagna, 42100

    Michele Panebianco, MD, +390522296858, michele.panebianco@ausl.re.it

    Recruiting

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Apulia, 71013

    Evaristo Maiello, MD, +390882410640, e.maiello@operapadrepio.it

    Recruiting

  • Ospedale Santa Maria Della Misericordia Di Perugia

    Terni, Umbria, 05100

    Fausto Riola, MD, +390755784211, fausto.roila@unipg.it

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Venito, 37134

    Davide Melisi, MD, PhD, +390458128120, davide.melisi@univr.it

    Recruiting

Other trials in Italy

South Korea6 sites, 6 recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

    Jun Eul Hwang, MD, +82613797622, hjunyl@naver.com

    Recruiting

  • National Cancer Center

    Seoul, Gyeonggido, 10408

    Woo Jin Lee, MD, +82319201612, lwj@ncc.re.kr

    Recruiting

  • CHA Bundang Medical Center, CHA University

    Seoul, Gyeonggido, 13496

    Hong Jae Chon, MD, +82317803453, minidoctor@cha.ac.kr

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Do-Youn Oh, MD, +82220720701, ohdoyoun@snu.ac.kr

    Recruiting

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, Seoul Teugbyeolsi, 03722

    Hye Jin Choi, MD, PhD, +82222288133, choihj@yuhs.ac

    Recruiting

  • Asan Medical Center - PPDS

    Seoul, 05505

    Baek-yeol Ryoo, MD, PhD, +82230103211, ryooby@amc.seoul.kr

    Recruiting

Other trials in South Korea

Australia5 sites, 4 recruiting

  • Canberra Region Cancer Centre

    Garran, Australia Capital Territory, 2605

    Ankit Jain, MBBS, +61266565733, Ankit.Jain@act.gov.au

    Recruiting

  • Austin Hospital

    Heidelberg, Victoria, 3084

    Niall Tebbutt, +61394965763, niall.tebbutt@austin.org.au

    Recruiting

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5307

    Sue Yeend, +61882922204, sue.yeend@icon.team

    Recruiting

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

    Rebecca Weselman, +61894389599, rebecca.weselman2@sjog.org.au

    Recruiting

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

    Withdrawn

Other trials in Australia

France5 sites, 5 recruiting

  • Hopital Jean Minjoz

    Besançon, Doubs, 25030

    Angélique Vienot, MD, +33381479999, a3vienot@chu-besancon.fr

    Recruiting

  • Centre François Baclesse

    Caen, Calvados, 14076

    Natacha Duval, +33231455050, natacha.duval@baclesse.unicancer.fr

    Recruiting

  • Hopitaux de La Timone

    Marseille, Bouches-du-Rhône, 13005

    Laetitia Dahan, MD, +33491386023, laetitia.dahan@ap-hm.fr

    Recruiting

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

    Rennes, Ille-et-Vilaine, 35000

    Samuel Le Sourd, MD, +33299253089, s.lesourd@rennes.unicancer.fr

    Recruiting

  • Hôpital de Rangueil

    Toulouse, Haute-Garonne, 69437

    Rosine Guimbaud, MD, PhD, +33561322142, guimbaud.r@chu-toulouse.fr

    Recruiting

Other trials in France

Germany5 sites, 3 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

    Uwe Pelzer, MD, PhD, +4930450553844, uwe.pelzer@charite.de

    Recruiting

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Saxony, 01307

    Gunnar Folprecht, MD, +493514584794, gunnar.folprecht@uniklinikum-dresden.de

    Not yet recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Active, not recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Pavlos Missios, MD, +4970712984457, pavlos.missios@med.uni-tuebingen.de

    Recruiting

  • Klinikum Weiden

    Weiden, 92637

    Active, not recruiting

Other trials in Germany

United Kingdom3 sites, 2 recruiting

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, Aberdeen City, AB25 2ZN

    Active, not recruiting

  • Hammersmith Hospital

    London, City of London, W12 0HS

    Rowan Dulson, rowan.dulson@nhs.net

    Recruiting

  • Derriford Hospital

    Plympton, Devon, PL6 8DH

    Derriford Hospital University Hospitals Plymouth, plh-tr.oncologyresearch@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
SBP-101, Nab-paclitaxel, Gemcitabine, Placebo
Keywords
SBP-101
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBP-101Drug

    Also called ivospemin

    small molecule polyamine metabolic inhibitor for subcutaneous injection

  • Nab-paclitaxelDrug

    Also called Abraxane

    paclitaxel protein-bound particles for injectable suspension

  • GemcitabineDrug

    Also called Gemzar

    gemcitabine for injection

  • PlaceboOther

    Normal Saline

Study groups in NCT05254171
Study groupRoleWhat they receive
Experimental ArmExperimentalSBP-101 + Nab-paclitaxel and Gemcitabine
Receives: Drug: SBP-101; Drug: Nab-paclitaxel; Drug: Gemcitabine
Control ArmPlacebo comparatorPlacebo + Nab-Paclitaxel and Gemcitabine
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Compare OS between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine

    Measured: From date of first dose up to 100 weeks or until death

Secondary outcomes (1)

  1. Progression Free Survival (PFS)

    Compare PFS between SBP-101 and placebo

    Measured: From date of first dose up to 100 weeks or until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start8 Aug 2022
  3. Primary completion29 Aug 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization to Experimental Arm vs. Control Arm
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254171
Sponsor's protocol ID
CL-SBP-101-04
Acronym
ASPIRE
Status last verified
Jul 2024
First submitted
13 Jan 2022
Last updated
6 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SBP-101, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer Metastatic and Pancreatic Ductal Adenocarcinoma, run by Panbela Therapeutics, Inc. at 93 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Spain, United States, Belgium, Austria, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Bragg, MPH (952-479-1196, rbragg@panbela.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From date of first dose up to 100 weeks or until death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05254171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.

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