Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
- Conditions
- Pancreatic Ductal AdenocarcinomaPancreatic Cancer MetastaticPancreatic Cancer Stage IV
- Interventions
- Registration Number
- NCT05254171
- Lead Sponsor
- Panbela Therapeutics, Inc.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Nab-paclitaxel Placebo + Nab-Paclitaxel and Gemcitabine Experimental Arm Gemcitabine SBP-101 + Nab-paclitaxel and Gemcitabine Experimental Arm SBP-101 SBP-101 + Nab-paclitaxel and Gemcitabine Experimental Arm Nab-paclitaxel SBP-101 + Nab-paclitaxel and Gemcitabine Control Arm Placebo Placebo + Nab-Paclitaxel and Gemcitabine Control Arm Gemcitabine Placebo + Nab-Paclitaxel and Gemcitabine
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From date of first dose up to 100 weeks or until death 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
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) From date of first dose up to 100 weeks or until death Compare PFS between SBP-101 and placebo
Trial Locations
- Locations (92)
Derriford Hospital
🇬🇧Plympton, Devon, United Kingdom
CHU UCL Namur asbl - Site Godinne
🇧🇪Yvoir, Namur, Belgium
Onze-Lieve-Vrouwziekenhuis
🇧🇪Aalst, Oost-Vlaanderen, Belgium
Azienda Ospedaliera Universitaria Integrata Di Verona
🇮🇹Verona, Venito, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia-Vialle Camillo Golgi 19
🇮🇹Pavia, Italy
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
🇪🇸Sevilla, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Aberdeen Royal Infirmary - PPDS
🇬🇧Aberdeen, Aberdeen City, United Kingdom
Hammersmith Hospital
🇬🇧London, City Of London, United Kingdom
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, 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 am Wörthersee, Kärnten, Austria
Universitätsklinikum St. Pölten
🇦🇹Sankt Pölten, Niederösterreich, Austria
Ordensklinikum Linz, Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H
🇦🇹Linz, Oberösterreich, Austria
Pyhrn-Eisenwurzen Klinikum Steyr
🇦🇹Steyr, Oberösterreich, Austria
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Oberösterreich, 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
🇧🇪Bruxelles, Belgique, Belgium
Hôpital de Jolimont
🇧🇪La Louvière, Hainaut, Belgium
Centre Hospitalier de l'Ardenne
🇧🇪Libramont, Luxembourg, Belgium
UZ Gent
🇧🇪Gent, 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, Sachsen, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Universitätsklinikum Tübingen
🇩🇪Tuebingen, Germany
Klinikum Weiden
🇩🇪Weiden, Germany
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
🇮🇹Milano, Lombardia, Italy
Instituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Ospedale degli Infermi
🇮🇹Candiolo, Piemonte, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, Puglia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
Ospedale Santa Maria Della Misericordia Di Perugia
🇮🇹Terni, Umbria, Italy
National Cancer Center
🇰🇷Seoul, Gyeonggido, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seoul, Gyeonggido, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Asan Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
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 Universitario HM Sanchinarro - CIOCC
🇪🇸Madrid, Madrid, Communidad Delaware, Spain
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca
🇪🇸El Palmar, Murcia, Spain
Clinica Universidad Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Navarra, 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