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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pancreatic Cancer Metastatic, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Stage IV

In brief

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.

Key facts

Study ID

NCT05254171

Run by

Panbela Therapeutics, Inc.

People needed

600

Starts

2022-08-08

Expected to finish

2027-01-01

Last updated by the study team

2024-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Centre Hospitalier de l'Ardenne — Libramont, Luxembourg, Belgium (enrolling)
• CHU UCL Namur asbl - Site Godinne — Yvoir, Namur, Belgium (enrolling)
• A.ö. Krankenhaus der Barmherzigen Brüder — Wein, Austria (enrolling)
• Hôpital de Jolimont — La Louvière, Hainaut, Belgium (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Kepler Universitätsklinikum Linz — Linz, Austria (enrolling)
• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Imelda VZW — Bonheiden, Antwerpen, Belgium (enrolling)
• Medical Oncology Associates - Spokane — Spokane, Washington, United States (enrolling)
• MultiCare Regional Cancer Center - Tacoma — Tacoma, Washington, United States (enrolling)
• Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Canberra Region Cancer Centre — Garran, Australia Capital Territory, Australia (enrolling)
• University of Rochester — Rochester, New York, United States (enrolling)
• Ashford Cancer Centre Research — Kurralta Park, South Australia, Australia (enrolling)
• Austin Hospital — Heidelberg, Victoria, Australia (enrolling)
• St John of God Murdoch Hospital — Murdoch, Western Australia, Australia (enrolling)
• Klinikum Klagenfurt Am Woerthersee — Klagenfurt, Carinthia, Austria (enrolling)
• Universitätsklinikum St. Pölten — Sankt Pölten, Lower Austria, Austria (enrolling)
• HOPE Cancer Center of East Texas — Tyler, Texas, United States (enrolling)
• Landesklinikum Wiener Neustadt — Wiener Neustadt, Austria (enrolling)
• Klinikum Wels-Grieskirchen GmbH — Wels, Upper Austria, Austria (enrolling)
• Landeskrankenhaus Feldkirch — Rankweil, Vorarlberg, Austria (enrolling)
• Onze-Lieve-Vrouwziekenhuis — Aalst, Oost-Vlaanderen, Belgium (enrolling)

Full record on ClinicalTrials.gov

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