Recruiting
Phase 2
Phase 3

Nab-Paclitaxel & Gemcitabine

Sponsor:

Panbela Therapeutics, Inc.

Code:

NCT05254171

Conditions

Pancreatic Cancer Metastatic

Pancreatic Ductal Adenocarcinoma

Pancreatic Cancer Stage IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SBP-101

Nab-paclitaxel

Gemcitabine

Placebo

Study Details

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.

Conditions

Pancreatic Cancer Metastatic

Pancreatic Ductal Adenocarcinoma

Pancreatic Cancer Stage IV

Study ID

NCT05254171

Start date

Aug 8, 2022

Status verified date

Jul, 2024

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Aug 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm

SBP-101 + Nab-paclitaxel and Gemcitabine

placebo comparator: Control Arm

Placebo + Nab-Paclitaxel and Gemcitabine

Interventions

SBP-101

small molecule polyamine metabolic inhibitor for subcutaneous injection

Nab-paclitaxel

paclitaxel protein-bound particles for injectable suspension

Gemcitabine

gemcitabine for injection

Placebo

Normal Saline

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: From date of first dose up to 100 weeks or until death ]

Central Contacts and Locations

Central contacts

Rachel Bragg, MPH

952-479-1196rbragg@panbela.com

Tammy Groene

952-479-1196tgroene@panbela.com

Locations

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Contacts

Jagruti Khandhadia

714-446-5900jagruti.khandhadia@providence.org

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Jill Lacy, MD

203-737-1600jill.lacy@yale.edu

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202-2643

Contacts

Philip Philip, MD

313-576-8728pphilip1@hfhs.org

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Navigator Office Nurse

212-342-5162cancerclinicaltrials@cumc.columbia.edu

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Chris LeFeber

585-275-0407chris_lefeber@urmc.rochester.edu

HOPE Cancer Center of East Texas

Recruiting

Tyler, Texas, United States, 75701

Contacts

Grace Loredo

903-592-6152grace.loredo@uthct.edu

Medical Oncology Associates - Spokane

Recruiting

Spokane, Washington, United States, 99208

Contacts

Monika Chaudhry, PhD

509-462-2273monika.chaudhry@aoncology.com

MultiCare Regional Cancer Center - Tacoma

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Samantha Blake

253-572-7320Samantha.Blake@multicare.org

Froedtert Hospital & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

414-805-8900cccto@mcw.edu

More Information

Sponsor

Panbela Therapeutics, Inc.

Last update posted

Nov 6, 2024

Last verified

Jul, 2024

Keywords

  • SBP-101

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Panbela Therapeutics, Inc. on 2024-11-06.