Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
NCT ID: NCT05254171
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
600 participants
INTERVENTIONAL
2022-08-08
2027-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
NCT03412799
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
NCT02570711
A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
NCT02399137
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
NCT02101021
Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
NCT01851174
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Arm
SBP-101 + Nab-paclitaxel and Gemcitabine
SBP-101
small molecule polyamine metabolic inhibitor for subcutaneous injection
Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension
Gemcitabine
gemcitabine for injection
Control Arm
Placebo + Nab-Paclitaxel and Gemcitabine
Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension
Gemcitabine
gemcitabine for injection
Placebo
Normal Saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SBP-101
small molecule polyamine metabolic inhibitor for subcutaneous injection
Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension
Gemcitabine
gemcitabine for injection
Placebo
Normal Saline
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Panbela Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael J Walker, MD
Role: STUDY_DIRECTOR
Panbela Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Medical College of Wisconsin Cancer Center Clinical Trials Office
Role: primary
Mandana Kamgar, Study Principle Investigator
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL-SBP-101-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.