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

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ClinicalTrials.gov Identifier: NCT05254171
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
Panbela Therapeutics, Inc.

Study Description
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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 PDA, including subjects who have received prior neoadjuvant or adjuvant treatment.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Stage IV Drug: SBP-101 Drug: Nab-paclitaxel Drug: Gemcitabine Other: Placebo Phase 2 Phase 3

Detailed Description:
The study will start with a 150-subject sentinel cohort and may continue with an expansion cohort depending on the results of a futility analysis to be performed when 104 required PFS events (death or disease progression, whichever comes first) are observed in the sentinel cohort.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization to Experimental Arm vs. Control Arm
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 8, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm
SBP-101 + Nab-paclitaxel and Gemcitabine
 Drug: SBP-101
small molecule polyamine metabolic inhibitor for subcutaneous injection
Other Name: diethyl dihydroxyhomospermine

Drug: Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension
Other Name: Abraxane

Drug: Gemcitabine
gemcitabine for injection
Other Name: Gemzar
Placebo Comparator: Control Arm
Placebo + Nab-Paclitaxel and Gemcitabine
 Drug: Nab-paclitaxel
paclitaxel protein-bound particles for injectable suspension
Other Name: Abraxane

Drug: Gemcitabine
gemcitabine for injection
Other Name: Gemzar

Other: Placebo
Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization (Day 1) until death from any cause assessed up to 36 months ]
    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


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Randomization (Day 1) until disease progression or death from any cause, whichever occurs first, assessed up to 36 months ]
    Compare PFS between SBP-101 and placebo


Other Outcome Measures:
  1. Overall Objective Response (ORR) [ Time Frame: Every 8 weeks during treatment for up to 36 months ]
    Compare ORR between SBP-101 and placebo

  2. Disease Control Rate (DCR) [ Time Frame: At least 16 weeks ]
    Compare DCR between SBP-101 and placebo

  3. Duration of Response (DoR) [ Time Frame: Onset of CR or PR until disease progression assessed up to 36 months ]
    Compare DoR between SBP-101 and placebo

  4. Quality of Life (QOL) Questionnaires: EORTC QLC-C30 [ Time Frame: Every 4 weeks during treatment for up to 36 months ]
    Compare QOL changes in scores between SBP-101 and placebo

  5. Quality of Life (QOL) Questionnaires: QLQ-PAN26 [ Time Frame: Every 4 weeks during treatment for up to 36 months ]
    Compare QOL changes in scores between SBP-101 and placebo

  6. Number of Subjects with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 36 months ]
    Compare Safety and Tolerability of SBP-101 to placebo when administered in combination with nab-paclitaxel and gemcitabine

  7. Exploratory [ Time Frame: Baseline to week 8 and maximum decrease overall assessed for up to 36 months ]
    Compare effects of SBP-101 and placebo on blood levels of CA 19-9 and circulating tumor DNA (cT DNA)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. Subjects with pancreatic acinar cell carcinoma may also be included.
  • 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/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 during the study. All sexually active males must also use an adequate method of contraception during the study. 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 msec at Baseline.
  • Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required.

Exclusion Criteria:

  • Subjects known to be BRCA (BReast CAncer gene) positive.
  • Subjects taking metformin. Diabetic subjects on treatment with metformin, or any other derivative thereof, must discontinue it while on study (other diabetic medications are allowed).
  • History of retinopathy or macular degeneration.
  • 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).
  • Occurrence of deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism (PE), or other thromboembolic event 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 of the start of study 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05254171


Contacts
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Contact: Rachel Bragg, MPH 952-479-1196 ext 177 rbragg@panbela.com
Contact: Tammy Groene 952-479-1196 ext 170 tgroene@panbela.com

Locations
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United States, Arkansas
Genesis Cancer and Blood Institute (SCRI) Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Madison Huett    501-624-7700 ext 63839    Madison.Huett@aoncology.com   
United States, Texas
HOPE Cancer Center of East Texas Recruiting
Tyler, Texas, United States, 75701
Contact: Grace Loredo    903-595-7093    grace.loredo@uthct.edu   
United States, Wisconsin
Froedtert Hospital & the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office    414-805-8900    cccto@mcw.edu   
Contact: Mandana Kamgar, Study Principle Investigator         
Sponsors and Collaborators
Panbela Therapeutics, Inc.
Investigators
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Study Director: Michael J Walker, MD Panbela Therapeutics, Inc.
More Information
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Responsible Party: Panbela Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05254171    
Other Study ID Numbers: CL-SBP-101-04
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Panbela Therapeutics, Inc.:
SBP-101
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs