RECRUITING

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

Conditions

Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Stage IV SBP-101

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-08-08

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05254171

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Rachel Bragg, MPH

CONTACT

952-479-1196

rbragg@panbela.com

Tammy Groene

CONTACT

952-479-1196

tgroene@panbela.com

Principal Investigator

Michael J Walker, MD

STUDY_DIRECTOR

Panbela Therapeutics, Inc.

Study Locations (Sites)

Genesis Cancer and Blood Institute (SCRI)

Hot Springs, Arkansas, 71913

United States

Providence Medical Foundation

Fullerton, California, 92835

United States

Yale Cancer Center

New Haven, Connecticut, 06519

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Henry Ford Health System

Detroit, Michigan, 48202-2643

United States

CentraCare Health

Saint Cloud, Minnesota, 56303

United States

Columbia University Medical Center

New York, New York, 10032

United States

University of Rochester

Rochester, New York, 14642

United States

Mark H Zangmeister Center - SCRI - PPDS

Columbus, Ohio, 43219

United States

Tennessee Oncology NASH - SCRI - PPDS

Nashville, Tennessee, 37203

United States

HOPE Cancer Center of East Texas

Tyler, Texas, 75701

United States

Medical Oncology Associates - Spokane

Spokane, Washington, 99208

United States

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, 98405

United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Panbela Therapeutics, Inc.

Michael J Walker, MD, STUDY_DIRECTOR, Panbela Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-08

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2022-08-08

Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

SBP-101

Additional Relevant MeSH Terms

Pancreatic Cancer Metastatic
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer Stage IV