This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    PANBELA CL-SBP-101-04 (ASPIRE)
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05254171
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Panbela Therapeutics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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:
This trial will enroll approximately 600 patients to evaluate the effect of SBP-101 on Overall Survival when administered with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel and a placebo. Secondary endpoints include Progression-free survival, radiologic responses to treatment, and Quality of Life measures. An independent, external Data Safety Monitoring Board (DSMB) will monitor safety and efficacy and a planned futility analysis.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 : August 29, 2026
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: ivospemin

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From date of first dose up to 100 weeks or until death ]
    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: From date of first dose up to 100 weeks or until death ]
    Compare PFS between SBP-101 and placebo


Other Outcome Measures:
  1. Overall Objective Response (ORR) [ Time Frame: Up to 100 weeks ]
    Compare ORR between SBP-101 and placebo

  2. Disease Control Rate (DCR) [ Time Frame: Up to 100 weeks ]
    Compare DCR between SBP-101 and placebo

  3. Duration of Response (DoR) [ Time Frame: Up to 100 weeks ]
    Compare DoR between SBP-101 and placebo

  4. Quality of Life (QOL) Questionnaires: EORTC QLC-C30 [ Time Frame: Up to 100 weeks ]
    Compare QOL changes in scores between SBP-101 and placebo

  5. Quality of Life (QOL) Questionnaires: QLQ-PAN26 [ Time Frame: Up to 100 weeks ]
    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 100 weeks ]
    Compare Safety and Tolerability of SBP-101 to placebo when administered in combination with nab-paclitaxel and gemcitabine

  7. Exploratory [ Time Frame: Up to 100 weeks ]
    Compare effects of SBP-101 and placebo on blood levels of carbohydrate antigen (CA) CA 19-9 and circulating tumor DNA (cT DNA). ctDNA analysis will be done only on subjects enrolled prior to Interim Analysis.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
  • 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.

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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Rachel Bragg, MPH 952-479-1196 rbragg@panbela.com
Contact: Tammy Groene 952-479-1196 tgroene@panbela.com

Locations
Show Show 92 study locations
Sponsors and Collaborators
Panbela Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Michael J Walker, MD Panbela Therapeutics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
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
Paclitaxel
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites