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

April 15, 2024 updated by: Panbela Therapeutics, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australia Capital Territory
      • Garran, Australia Capital Territory, Australia, 2605
        • Recruiting
        • Canberra Region Cancer Centre
        • Contact:
    • New South Wales
      • Tweed Heads, New South Wales, Australia, 2485
        • Withdrawn
        • The Tweed Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, 5307
        • Recruiting
        • Ashford Cancer Centre Research
        • Contact:
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Austria
      • Linz, Austria, 4021
      • Salzburg, Austria, 5020
        • Active, not recruiting
        • Salzburg Cancer Research Institute
      • Wein, Austria, 1020
        • Recruiting
        • A.ö. Krankenhaus der Barmherzigen Brüder
        • Contact:
      • Wiener Neustadt, Austria, 2700
    • Kärnten
      • Klagenfurt am Wörthersee, Kärnten, Austria, 9020
        • Recruiting
        • Klinikum Klagenfurt Am Woerthersee
        • Contact:
    • Niederösterreich
      • Sankt Pölten, Niederösterreich, Austria, 3100
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Not yet recruiting
        • Ordensklinikum Linz, Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H
        • Contact:
      • Steyr, Oberösterreich, Austria, 4400
        • Withdrawn
        • Pyhrn-Eisenwurzen Klinikum Steyr
      • Wels, Oberösterreich, Austria, 4600
    • Vorarlberg
      • Rankweil, Vorarlberg, Austria, 6830
        • Recruiting
        • Landeskrankenhaus Feldkirch
        • Contact:
  • Belgium
      • Charleroi, Belgium, 6000
        • Recruiting
        • Grand Hopital de Charleroi asbl
        • Contact:
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2820
    • Belgique
      • Bruxelles, Belgique, Belgium
    • Hainaut
      • La Louvière, Hainaut, Belgium, 7100
    • Luxembourg
      • Libramont, Luxembourg, Belgium, 6800
        • Recruiting
        • Centre Hospitalier de l'Ardenne
        • Contact:
    • Namur
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Gent, Oost-Vlaanderen, Belgium, 9000
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium, 8500
  • France
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13005
        • Recruiting
        • Hopitaux de La Timone
        • Contact:
    • Calvados
    • Doubs
      • Besançon, Doubs, France, 25030
        • Recruiting
        • Hopital Jean Minjoz
        • Contact:
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 69437
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Recruiting
        • EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
        • Contact:
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
      • Hamburg, Germany, 22763
        • Active, not recruiting
        • Asklepios Klinik Altona
      • Tuebingen, Germany, 72076
      • Weiden, Germany, 92637
        • Active, not recruiting
        • Klinikum Weiden
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia-Vialle Camillo Golgi 19
        • Contact:
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
        • Contact:
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • Recruiting
        • Azienda Unita Sanita Locale di Reggio Emilia IRCCS
        • Contact:
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
        • Contact:
      • Milano, Lombardia, Italy, 20141
        • Recruiting
        • Instituto Europeo di Oncologia
        • Contact:
    • Piemonte
      • Candiolo, Piemonte, Italy, 10060
    • Puglia
      • San Giovanni Rotondo, Puglia, Italy, 71013
        • Recruiting
        • Ospedale Casa Sollievo Della Sofferenza IRCCS
        • Contact:
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
    • Umbria
      • Terni, Umbria, Italy, 05100
        • Recruiting
        • Ospedale Santa Maria Della Misericordia Di Perugia
        • Contact:
    • Venito
      • Verona, Venito, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Di Verona
        • Contact:
  • Korea, Republic of
      • Hwasun, Korea, Republic of, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center - PPDS
        • Contact:
    • Gyeonggido
      • Seoul, Gyeonggido, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
        • Contact:
          • Woo Jin Lee, MD
          • Phone Number: +82319201612
          • Email: lwj@ncc.re.kr
      • Seoul, Gyeonggido, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Contact:
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System - PPDS
        • Contact:
          • Hye Jin Choi, MD, PhD
          • Phone Number: +82222288133
          • Email: choihj@yuhs.ac
  • Spain
      • A Coruña, Spain, 15006
        • Active, not recruiting
        • Hospital Universitario A Coruña
      • Badajoz, Spain, 06011
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
        • Contact:
      • Barcelona, Spain, 08908
        • Recruiting
        • Ico L'Hospitalet - Hospital Duran I Reynals
        • Contact:
      • Girona, Spain, 17007
        • Recruiting
        • Institut Català D'Oncologia Girona
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
      • Madrid, Spain, 28048
      • Madrid, Spain, 28033
        • Recruiting
        • MD Anderson Cancer Center Madrid - España
        • Contact:
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga - Hospital General
        • Contact:
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio - PPDS
        • Contact:
      • Sevilla, Spain, 41071
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
        • Contact:
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
    • Jaen
      • Jaén, Jaen, Spain, 23007
        • Recruiting
        • Hospital Universitario de Jaén
        • Contact:
    • Madrid
      • Barcelona, Madrid, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
    • Madrid, Communidad Delaware
      • Madrid, Madrid, Communidad Delaware, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro - CIOCC
        • Contact:
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad Navarra
        • Contact:
          • Mariano Ponz-Sarvisé, MD, PhD
          • Phone Number: +34948255400
          • Email: mponz@unav.es
      • Pamplona, Navarra, Spain, 31008
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
  • United Kingdom
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Active, not recruiting
        • Aberdeen Royal Infirmary - PPDS
    • City Of London
      • London, City Of London, United Kingdom, W12 0HS
    • Devon
      • Plympton, Devon, United Kingdom, PL6 8DH
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Withdrawn
        • Genesis Cancer and Blood Institute (SCRI)
    • California
      • Fullerton, California, United States, 92835
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale Cancer Center
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Active, not recruiting
        • MedStar Georgetown University Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202-2643
        • Recruiting
        • Henry Ford Health System
        • Contact:
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • Withdrawn
        • CentraCare Health
    • New York
      • New York, New York, United States, 10032
      • Rochester, New York, United States, 14642
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Terminated
        • Mark H Zangmeister Center - SCRI - PPDS
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Tyler, Texas, United States, 75701
        • Recruiting
        • HOPE Cancer Center of East Texas
        • Contact:
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates - Spokane
        • Contact:
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Regional Cancer Center - Tacoma
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital & the Medical College of Wisconsin
        • Contact:
          • Mandana Kamgar, Study Principle Investigator
        • Contact:
          • Medical College of Wisconsin Cancer Center Clinical Trials Office
          • Phone Number: 414-805-8900
          • Email: cccto@mcw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
SBP-101 + Nab-paclitaxel and Gemcitabine
Drug: SBP-101
small molecule polyamine metabolic inhibitor for subcutaneous injection
Other Names:
  • ivospemin
Drug: Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension
Other Names:
  • Abraxane
Drug: Gemcitabine
gemcitabine for injection
Other Names:
  • Gemzar
Placebo Comparator: Control Arm
Placebo + Nab-Paclitaxel and Gemcitabine
Drug: Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension
Other Names:
  • Abraxane
Drug: Gemcitabine
gemcitabine for injection
Other Names:
  • Gemzar
Other: Placebo
Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 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
From date of first dose up to 100 weeks or until death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From date of first dose up to 100 weeks or until death
Compare PFS between SBP-101 and placebo
From date of first dose up to 100 weeks or until death

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Objective Response (ORR)
Time Frame: Up to 100 weeks
Compare ORR between SBP-101 and placebo
Up to 100 weeks
Disease Control Rate (DCR)
Time Frame: Up to 100 weeks
Compare DCR between SBP-101 and placebo
Up to 100 weeks
Duration of Response (DoR)
Time Frame: Up to 100 weeks
Compare DoR between SBP-101 and placebo
Up to 100 weeks
Quality of Life (QOL) Questionnaires: EORTC QLC-C30
Time Frame: Up to 100 weeks
Compare QOL changes in scores between SBP-101 and placebo
Up to 100 weeks
Quality of Life (QOL) Questionnaires: QLQ-PAN26
Time Frame: Up to 100 weeks
Compare QOL changes in scores between SBP-101 and placebo
Up to 100 weeks
Number of Subjects with treatment-emergent adverse events as assessed by CTCAE v5.0
Time Frame: Up to 100 weeks
Compare Safety and Tolerability of SBP-101 to placebo when administered in combination with nab-paclitaxel and gemcitabine
Up to 100 weeks
Exploratory
Time Frame: Up to 100 weeks
Compare effects of SBP-101 and placebo on blood levels of carbohydrate antigen (CA) CA 19-9 and circulating tumor DNA (cT DNA). ctDNA analysis will be done only on subjects enrolled prior to Interim Analysis.
Up to 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Panbela Therapeutics, Inc.

Investigators

  • Study Director: Michael J Walker, MD, Panbela Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2022

Primary Completion (Estimated)

August 29, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-SBP-101-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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