Actively Recruiting
Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
Led by Panbela Therapeutics, Inc. · Updated on 2024-11-06
600
Participants Needed
93
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- Previously untreated for metastatic pancreatic ductal adenocarcinoma with diagnosis within the past 3 months.
- Expected to receive standard treatment with gemcitabine and nab-paclitaxel.
- Life expectancy of at least 3 months.
- Measurable disease on CT or MRI scan by RECIST v1.1 criteria.
- ECOG Performance Status 0-1.
- Adult aged 18 years or older, male or female.
- Females of child-bearing potential must have a negative pregnancy test within 14 days before treatment and use contraception from 2 weeks before first dose until 6 months after last dose.
- Adequate bone marrow, liver, and kidney function as specified in the protocol.
- QTc interval ≤ 470 ms for women and ≤ 450 ms for men on baseline ECG.
- Willing and able to provide written informed consent.
You will not qualify if you...
- Known BRCA 1 or BRCA 2 gene mutations from prior germline or somatic testing.
- Use of metformin or similar diabetes medication within 5 days before starting treatment and during the study.
- History of retinopathy or risk factors for retinal detachment including recent eye surgery or severe eye injury.
- Severe or uncontrolled systemic disease or conditions that may affect study participation or compliance.
- Medical or psychiatric conditions that impair informed consent or protocol completion.
- Presence of islet-cell or pancreatic neuroendocrine tumors or mixed adenocarcinoma-neuroendocrine carcinoma.
- Symptomatic central nervous system malignancy or metastasis.
- Serum albumin below 30 g/L.
- Recent deep vein thrombosis, pulmonary embolism, or other thromboembolic events during screening.
- Active bacterial, fungal, or viral infections requiring systemic therapy.
- Known active HIV, hepatitis B, or hepatitis C infection.
- Interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reactions.
- Recent myocardial infarction, severe unstable angina, or advanced congestive heart failure.
- Pregnant or breastfeeding.
- Major surgery within 4 weeks before starting study treatment without full recovery.
- Known allergy to any study treatment components.
- Participation in another clinical trial within 4 weeks before first dose.
- Any history of hydroxychloroquine use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 93 locations
1
Genesis Cancer and Blood Institute (SCRI)
Hot Springs, Arkansas, United States, 71913
Withdrawn
2
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
4
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Active, Not Recruiting
5
Henry Ford Health System
Detroit, Michigan, United States, 48202-2643
Actively Recruiting
6
CentraCare Health
Saint Cloud, Minnesota, United States, 56303
Withdrawn
7
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
8
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
9
Mark H Zangmeister Center - SCRI - PPDS
Columbus, Ohio, United States, 43219
Terminated
10
Tennessee Oncology NASH - SCRI - PPDS
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
11
HOPE Cancer Center of East Texas
Tyler, Texas, United States, 75701
Actively Recruiting
12
Medical Oncology Associates - Spokane
Spokane, Washington, United States, 99208
Actively Recruiting
13
MultiCare Regional Cancer Center - Tacoma
Tacoma, Washington, United States, 98405
Actively Recruiting
14
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
15
Canberra Region Cancer Centre
Garran, Australia Capital Territory, Australia, 2605
Actively Recruiting
16
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Withdrawn
17
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia, 5307
Actively Recruiting
18
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
19
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
20
Klinikum Klagenfurt Am Woerthersee
Klagenfurt, Carinthia, Austria, 9020
Actively Recruiting
21
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, Austria, 3100
Actively Recruiting
22
Ordensklinikum Linz, Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H
Linz, Upper Austria, Austria, 4020
Not Yet Recruiting
23
Pyhrn-Eisenwurzen Klinikum Steyr
Steyr, Upper Austria, Austria, 4400
Withdrawn
24
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria, 4600
Actively Recruiting
25
Landeskrankenhaus Feldkirch
Rankweil, Vorarlberg, Austria, 6830
Actively Recruiting
26
Kepler Universitätsklinikum Linz
Linz, Austria, 4021
Actively Recruiting
27
Salzburg Cancer Research Institute
Salzburg, Austria, 5020
Active, Not Recruiting
28
A.ö. Krankenhaus der Barmherzigen Brüder
Wein, Austria, 1020
Actively Recruiting
29
Landesklinikum Wiener Neustadt
Wiener Neustadt, Austria, 2700
Actively Recruiting
30
Imelda VZW
Bonheiden, Antwerpen, Belgium, 2820
Actively Recruiting
31
Cliniques Universitaires Saint-Luc
Brussels, Belgique, Belgium
Not Yet Recruiting
32
Hôpital de Jolimont
La Louvière, Hainaut, Belgium, 7100
Actively Recruiting
33
Centre Hospitalier de l'Ardenne
Libramont, Luxembourg, Belgium, 6800
Actively Recruiting
34
CHU UCL Namur asbl - Site Godinne
Yvoir, Namur, Belgium, 5530
Actively Recruiting
35
Onze-Lieve-Vrouwziekenhuis
Aalst, Oost-Vlaanderen, Belgium, 9300
Actively Recruiting
36
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
37
AZ Groeninge
Kortrijk, West-Vlaanderen, Belgium, 8500
Actively Recruiting
38
Grand Hopital de Charleroi asbl
Charleroi, Belgium, 6000
Actively Recruiting
39
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
40
CHU de Liège
Liège, Belgium, 4000
Actively Recruiting
41
Hopitaux de La Timone
Marseille, Bouches-du-Rhône, France, 13005
Actively Recruiting
42
Centre François Baclesse
Caen, Calvados, France, 14076
Actively Recruiting
43
Hopital Jean Minjoz
Besançon, Doubs, France, 25030
Actively Recruiting
44
Hôpital de Rangueil
Toulouse, Haute-Garonne, France, 69437
Actively Recruiting
45
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes, Ille-et-Vilaine, France, 35000
Actively Recruiting
46
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, Germany, 01307
Not Yet Recruiting
47
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
48
Asklepios Klinik Altona
Hamburg, Germany, 22763
Active, Not Recruiting
49
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
50
Klinikum Weiden
Weiden, Germany, 92637
Active, Not Recruiting
51
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Apulia, Italy, 71013
Actively Recruiting
52
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
53
Azienda Unita Sanita Locale di Reggio Emilia IRCCS
Reggio Emilia, Emilia-Romagna, Italy, 42100
Actively Recruiting
54
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, Italy, 20132
Actively Recruiting
55
Instituto Europeo Di Oncologia
Milan, Lombardy, Italy, 20141
Actively Recruiting
56
Ospedale degli Infermi
Candiolo, Piedmont, Italy, 10060
Completed
57
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56126
Actively Recruiting
58
Ospedale Santa Maria Della Misericordia Di Perugia
Terni, Umbria, Italy, 05100
Actively Recruiting
59
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Venito, Italy, 37134
Actively Recruiting
60
Fondazione IRCCS Policlinico San Matteo di Pavia-Vialle Camillo Golgi 19
Pavia, Italy, 27100
Actively Recruiting
61
National Cancer Center
Seoul, Gyeonggido, South Korea, 10408
Actively Recruiting
62
CHA Bundang Medical Center, CHA University
Seoul, Gyeonggido, South Korea, 13496
Actively Recruiting
63
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
64
Severance Hospital Yonsei University Health System - PPDS
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
65
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 58128
Actively Recruiting
66
Asan Medical Center - PPDS
Seoul, South Korea, 05505
Actively Recruiting
67
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
68
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
69
Hospital Universitario de Jaen
Jaén, Jaen, Spain, 23007
Actively Recruiting
70
Hospital de La Santa Creu i Sant Pau
Barcelona, Madrid, Spain, 08041
Actively Recruiting
71
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, Madrid, Communidad Delaware, Spain, 28050
Actively Recruiting
72
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
73
Clinica Universidad Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
74
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
75
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain, 48903
Actively Recruiting
76
Hospital Universitario A Coruña
A Coruña, Spain, 15006
Active, Not Recruiting
77
Hospital Universitario de Badajoz
Badajoz, Spain, 06011
Actively Recruiting
78
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Actively Recruiting
79
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
80
Institut Catala d'Oncologia Girona
Girona, Spain, 17007
Actively Recruiting
81
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
82
MD Anderson Cancer Center Madrid - España
Madrid, Spain, 28033
Actively Recruiting
83
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
84
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
85
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
86
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
87
Hospital Universitario La Paz - PPDS
Madrid, Spain, 28048
Actively Recruiting
88
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Spain, 29010
Actively Recruiting
89
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Actively Recruiting
90
Hospital Universitario Virgen Macarena
Seville, Spain, 41071
Actively Recruiting
91
Aberdeen Royal Infirmary - PPDS
Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
Active, Not Recruiting
92
Hammersmith Hospital
London, City of London, United Kingdom, W12 0HS
Actively Recruiting
93
Derriford Hospital
Plympton, Devon, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
R
Rachel Bragg, MPH
CONTACT
T
Tammy Groene
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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