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Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

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

NCT05254171•Panbela Therapeutics, Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

Locations (93)

Genesis Cancer and Blood Institute (SCRI)

Hot Springs, Arkansas, United States

Providence Medical Foundation

Fullerton, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Henry Ford Health System

Detroit, Michigan, United States

CentraCare Health

Saint Cloud, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Mark H Zangmeister Center - SCRI - PPDS

Columbus, Ohio, United States

Tennessee Oncology NASH - SCRI - PPDS

Nashville, Tennessee, United States

Key Dates

Start Date

August 8, 2022

Primary Completion Date

August 29, 2026

Completion Date

January 1, 2027

Last Updated

November 6, 2024

Enrollment

600

ESTIMATED participants

Conditions

Pancreatic Cancer MetastaticPancreatic Ductal AdenocarcinomaPancreatic Cancer Stage IV

Interventions

SBP-101

DRUG

Nab-paclitaxel

DRUG

Gemcitabine

DRUG

Placebo

OTHER

Contacts

Rachel Bragg, MPH

CONTACT

952-479-1196 rbragg@panbela.com

Tammy Groene

CONTACT

952-479-1196 tgroene@panbela.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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