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

Status: Recruiting
Location: See all (93) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Genesis Cancer and Blood Institute (SCRI)
WITHDRAWN
Hot Springs
California
Providence Medical Foundation
RECRUITING
Fullerton
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
MedStar Georgetown University Hospital
ACTIVE_NOT_RECRUITING
Washington D.c.
Michigan
Henry Ford Health System
RECRUITING
Detroit
Minnesota
CentraCare Health
WITHDRAWN
Saint Cloud
New York
Columbia University Medical Center
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Ohio
Mark H Zangmeister Center - SCRI - PPDS
TERMINATED
Columbus
Tennessee
Tennessee Oncology NASH - SCRI - PPDS
ACTIVE_NOT_RECRUITING
Nashville
Texas
HOPE Cancer Center of East Texas
RECRUITING
Tyler
Washington
Medical Oncology Associates - Spokane
RECRUITING
Spokane
MultiCare Regional Cancer Center - Tacoma
RECRUITING
Tacoma
Wisconsin
Froedtert Hospital & the Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Canberra Region Cancer Centre
RECRUITING
Garran
Austin Hospital
RECRUITING
Heidelberg
Ashford Cancer Centre Research
RECRUITING
Kurralta Park
St John of God Murdoch Hospital
RECRUITING
Murdoch
The Tweed Hospital
WITHDRAWN
Tweed Heads
Austria
Klinikum Klagenfurt Am Woerthersee
RECRUITING
Klagenfurt
Kepler Universitätsklinikum Linz
RECRUITING
Linz
Ordensklinikum Linz, Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H
NOT_YET_RECRUITING
Linz
Landeskrankenhaus Feldkirch
RECRUITING
Rankweil
Salzburg Cancer Research Institute
ACTIVE_NOT_RECRUITING
Salzburg
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
Pyhrn-Eisenwurzen Klinikum Steyr
WITHDRAWN
Steyr
A.ö. Krankenhaus der Barmherzigen Brüder
RECRUITING
Wein
Klinikum Wels-Grieskirchen GmbH
RECRUITING
Wels
Landesklinikum Wiener Neustadt
RECRUITING
Wiener Neustadt
Belgium
Onze-Lieve-Vrouwziekenhuis
RECRUITING
Aalst
Imelda VZW
RECRUITING
Bonheiden
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
Grand Hopital de Charleroi asbl
RECRUITING
Charleroi
UZ Gent
RECRUITING
Ghent
AZ Groeninge
RECRUITING
Kortrijk
Hôpital de Jolimont
RECRUITING
La Louvière
UZ Leuven
RECRUITING
Leuven
Centre Hospitalier de l'Ardenne
RECRUITING
Libramont
CHU de Liège
RECRUITING
Liège
CHU UCL Namur asbl - Site Godinne
RECRUITING
Yvoir
France
Hopital Jean Minjoz
RECRUITING
Besançon
Centre François Baclesse
RECRUITING
Caen
Hopitaux de La Timone
RECRUITING
Marseille
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
RECRUITING
Rennes
Hôpital de Rangueil
RECRUITING
Toulouse
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsklinikum Carl Gustav Carus an der TU Dresden
NOT_YET_RECRUITING
Dresden
Asklepios Klinik Altona
ACTIVE_NOT_RECRUITING
Hamburg
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Klinikum Weiden
ACTIVE_NOT_RECRUITING
Weiden
Italy
Ospedale degli Infermi
COMPLETED
Candiolo
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l - PPDS
RECRUITING
Meldola
Instituto Europeo Di Oncologia
RECRUITING
Milan
Ospedale San Raffaele S.r.l. - PPDS
RECRUITING
Milan
Fondazione IRCCS Policlinico San Matteo di Pavia-Vialle Camillo Golgi 19
RECRUITING
Pavia
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Azienda Unita Sanita Locale di Reggio Emilia IRCCS
RECRUITING
Reggio Emilia
Ospedale Casa Sollievo Della Sofferenza IRCCS
RECRUITING
San Giovanni Rotondo
Ospedale Santa Maria Della Misericordia Di Perugia
RECRUITING
Terni
Azienda Ospedaliera Universitaria Integrata Di Verona
RECRUITING
Verona
Republic of Korea
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Asan Medical Center - PPDS
RECRUITING
Seoul
CHA Bundang Medical Center, CHA University
RECRUITING
Seoul
National Cancer Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System - PPDS
RECRUITING
Seoul
Spain
Hospital Universitario A Coruña
ACTIVE_NOT_RECRUITING
A Coruña
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Hospital Universitario Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitario Cruces
RECRUITING
Barakaldo
Hospital de La Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
ICO l'Hospitalet - Hospital Duran i Reynals
RECRUITING
Barcelona
Hospital Universitario Virgen de La Arrixaca
RECRUITING
El Palmar
Institut Catala d'Oncologia Girona
RECRUITING
Girona
Hospital Universitario de Jaen
RECRUITING
Jaén
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro - CIOCC
RECRUITING
Madrid
Hospital Universitario La Paz - PPDS
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
MD Anderson Cancer Center Madrid - España
RECRUITING
Madrid
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING
Málaga
Clinica Universidad Navarra
RECRUITING
Pamplona
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocio - PPDS
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
United Kingdom
Aberdeen Royal Infirmary - PPDS
ACTIVE_NOT_RECRUITING
Aberdeen
Hammersmith Hospital
RECRUITING
London
Derriford Hospital
RECRUITING
Plympton
Contact Information
Primary
Rachel Bragg, MPH
rbragg@panbela.com
952-479-1196
Backup
Tammy Groene
tgroene@panbela.com
952-479-1196
Time Frame
Start Date: 2022-08-08
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 600
Treatments
Experimental: Experimental Arm
SBP-101 + Nab-paclitaxel and Gemcitabine
Placebo_comparator: Control Arm
Placebo + Nab-Paclitaxel and Gemcitabine
Sponsors
Leads: Panbela Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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