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

NCT05254171 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CL-SBP-101-04
• Study Type: interventional
• Target: 600
• Locations: 9 countries
• Sites: 88

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.

Conditions

Pancreatic Cancer Metastatic; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer Stage IV

Keywords

SBP-101

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (1)

• Progression Free Survival (PFS)

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

Other Outcomes (7)

• Overall Objective Response (ORR)

  Up to 100 weeks

• Disease Control Rate (DCR)

  Up to 100 weeks

• Duration of Response (DoR)

  Up to 100 weeks

Study Arms (2)

Experimental Arm

EXPERIMENTAL

SBP-101 + Nab-paclitaxel and Gemcitabine

Drug: SBP-101; Drug: Nab-paclitaxel; Drug: Gemcitabine

Control Arm

PLACEBO COMPARATOR

Placebo + Nab-Paclitaxel and Gemcitabine

Drug: Nab-paclitaxel; Drug: Gemcitabine; Other: Placebo

Interventions

SBP-101 DRUG

small molecule polyamine metabolic inhibitor for subcutaneous injection

Also known as: ivospemin

Experimental Arm

Nab-paclitaxel DRUG

paclitaxel protein-bound particles for injectable suspension

Also known as: Abraxane

Control Arm; Experimental Arm

Gemcitabine DRUG

gemcitabine for injection

Also known as: Gemzar

Control Arm; Experimental Arm

Placebo OTHER

Normal Saline

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Panbela Therapeutics, Inc.: lead

Study Sites (93)

Genesis Cancer and Blood Institute (SCRI)

Hot Springs, Arkansas, 71913, United States

WITHDRAWN

Providence Medical Foundation

Fullerton, California, 92835, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06519, United States

RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

ACTIVE NOT RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202-2643, United States

RECRUITING

CentraCare Health

Saint Cloud, Minnesota, 56303, United States

WITHDRAWN

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Mark H Zangmeister Center - SCRI - PPDS

Columbus, Ohio, 43219, United States

TERMINATED

Tennessee Oncology NASH - SCRI - PPDS

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

HOPE Cancer Center of East Texas

Tyler, Texas, 75701, United States

RECRUITING

Medical Oncology Associates - Spokane

Spokane, Washington, 99208, United States

RECRUITING

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, 98405, United States

RECRUITING

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Canberra Region Cancer Centre

Garran, Australia Capital Territory, 2605, Australia

RECRUITING

The Tweed Hospital

Tweed Heads, New South Wales, 2485, Australia

WITHDRAWN

Ashford Cancer Centre Research

Kurralta Park, South Australia, 5307, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

RECRUITING

St John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Klinikum Klagenfurt Am Woerthersee

Klagenfurt, Carinthia, 9020, Austria

RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

RECRUITING

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

Linz, Upper Austria, 4020, Austria

NOT YET RECRUITING

Pyhrn-Eisenwurzen Klinikum Steyr

Steyr, Upper Austria, 4400, Austria

WITHDRAWN

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, 4600, Austria

RECRUITING

Landeskrankenhaus Feldkirch

Rankweil, Vorarlberg, 6830, Austria

RECRUITING

Kepler Universitätsklinikum Linz

Linz, 4021, Austria

RECRUITING

Salzburg Cancer Research Institute

Salzburg, 5020, Austria

ACTIVE NOT RECRUITING

A.ö. Krankenhaus der Barmherzigen Brüder

Wein, 1020, Austria

RECRUITING

Landesklinikum Wiener Neustadt

Wiener Neustadt, 2700, Austria

RECRUITING

Imelda VZW

Bonheiden, Antwerpen, 2820, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, Belgique, Belgium

NOT YET RECRUITING

Hôpital de Jolimont

La Louvière, Hainaut, 7100, Belgium

RECRUITING

Centre Hospitalier de l'Ardenne

Libramont, Luxembourg, 6800, Belgium

RECRUITING

CHU UCL Namur asbl - Site Godinne

Yvoir, Namur, 5530, Belgium

RECRUITING

Onze-Lieve-Vrouwziekenhuis

Aalst, Oost-Vlaanderen, 9300, Belgium

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

Grand Hopital de Charleroi asbl

Charleroi, 6000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHU de Liège

Liège, 4000, Belgium

RECRUITING

Hopitaux de La Timone

Marseille, Bouches-du-Rhône, 13005, France

RECRUITING

Centre François Baclesse

Caen, Calvados, 14076, France

RECRUITING

Hopital Jean Minjoz

Besançon, Doubs, 25030, France

RECRUITING

Hôpital de Rangueil

Toulouse, Haute-Garonne, 69437, France

RECRUITING

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

Rennes, Ille-et-Vilaine, 35000, France

RECRUITING

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, 01307, Germany

NOT YET RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, 22763, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Klinikum Weiden

Weiden, 92637, Germany

ACTIVE NOT RECRUITING

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Apulia, 71013, Italy

RECRUITING

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

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

Azienda Unita Sanita Locale di Reggio Emilia IRCCS

Reggio Emilia, Emilia-Romagna, 42100, Italy

RECRUITING

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, 20132, Italy

RECRUITING

Instituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

RECRUITING

Ospedale degli Infermi

Candiolo, Piedmont, 10060, Italy

COMPLETED

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

RECRUITING

Ospedale Santa Maria Della Misericordia Di Perugia

Terni, Umbria, 05100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Venito, 37134, Italy

RECRUITING

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

Pavia, 27100, Italy

RECRUITING

National Cancer Center

Seoul, Gyeonggido, 10408, South Korea

RECRUITING

CHA Bundang Medical Center, CHA University

Seoul, Gyeonggido, 13496, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System - PPDS

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

RECRUITING

Asan Medical Center - PPDS

Seoul, 05505, South Korea

RECRUITING

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario de Jaen

Jaén, Jaen, 23007, Spain

RECRUITING

Hospital de La Santa Creu i Sant Pau

Barcelona, Madrid, 08041, Spain

RECRUITING

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, Madrid, Communidad Delaware, 28050, Spain

RECRUITING

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Clinica Universidad Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

RECRUITING

Hospital Universitario A Coruña

A Coruña, 15006, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Badajoz

Badajoz, 06011, Spain

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, 08908, Spain

RECRUITING

Institut Catala d'Oncologia Girona

Girona, 17007, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

MD Anderson Cancer Center Madrid - España

Madrid, 28033, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz - PPDS

Madrid, 28048, Spain

RECRUITING

Hospital Regional Universitario de Malaga - Hospital General

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41071, Spain

RECRUITING

Aberdeen Royal Infirmary - PPDS

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

ACTIVE NOT RECRUITING

Hammersmith Hospital

London, City of London, W12 0HS, United Kingdom

RECRUITING

Derriford Hospital

Plympton, Devon, PL6 8DH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael J Walker, MD

  Panbela Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Rachel Bragg, MPH

CONTACT

952-479-1196; rbragg@panbela.com

Tammy Groene

CONTACT

952-479-1196; tgroene@panbela.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization to Experimental Arm vs. Control Arm

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 24, 2022
• Study Start: August 8, 2022
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (11); AU (10); FR (5); DE (5); US (14); IT (10); KR (6); ES (24); GB (3)