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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05254171




Registration number
NCT05254171
Ethics application status
Date submitted
13/01/2022
Date registered
24/02/2022

Titles & IDs
Public title
Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
Scientific title
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
Secondary ID [1] 0 0
CL-SBP-101-04
Universal Trial Number (UTN)
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer Metastatic 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Pancreatic Cancer Stage IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SBP-101
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Other interventions - Placebo

Experimental: Experimental Arm - SBP-101 + Nab-paclitaxel and Gemcitabine

Placebo comparator: Control Arm - Placebo + Nab-Paclitaxel and Gemcitabine


Treatment: Drugs: SBP-101
small molecule polyamine metabolic inhibitor for subcutaneous injection

Treatment: Drugs: Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension

Treatment: Drugs: Gemcitabine
gemcitabine for injection

Other interventions: Placebo
Normal Saline
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of first dose up to 100 weeks or until death
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From date of first dose up to 100 weeks or until death

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Australia Capital TerritoryNSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Region Cancer Centre - Garran
Recruitment hospital [2] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [3] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
5307 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Arkansas
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California
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Connecticut
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District of Columbia
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Michigan
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Minnesota
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New York
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Ohio
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Tennessee
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Texas
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Washington
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Wisconsin
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Austria
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Kärnten
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Austria
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Niederösterreich
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Austria
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Oberösterreich
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Vorarlberg
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Linz
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Salzburg
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Wein
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Wiener Neustadt
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Belgium
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Antwerpen
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Belgium
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Belgique
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Hainaut
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Luxembourg
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Namur
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Charleroi
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Leuven
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Liège
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Sachsen
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Hamburg
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Tuebingen
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Weiden
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Italy
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Emilia-Romagna
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Lombardia
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Piemonte
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Puglia
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Venito
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Pavia
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Seoul
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Barcelona
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Cantabria
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Jaen
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Madrid, Communidad Delaware
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Spain
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Madrid
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Murcia
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Navarra
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Vizcaya
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A Coruña
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Badajoz
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Girona
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Spain
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Málaga
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Spain
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Sevilla
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United Kingdom
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Aberdeen City
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United Kingdom
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City Of London
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United Kingdom
State/province [68] 0 0
Devon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Panbela Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Walker, MD
Address 0 0
Panbela Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rachel Bragg, MPH
Address 0 0
Country 0 0
Phone 0 0
952-479-1196
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05254171