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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат SBP-101
  small molecule polyamine metabolic inhibitor for subcutaneous injection
• Препарат Nab-paclitaxel
  paclitaxel protein-bound particles for injectable suspension
• Препарат Gemcitabine
  gemcitabine for injection
• Другое Placebo
  Normal Saline

Первичные конечные точки

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

Вторичные конечные точки (1)

• Progression Free Survival (PFS) [Срок оценки: From date of first dose up to 100 weeks or until death]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 24 центра

• Hospital Universitario Germans Trias i Pujol — Badalona
• Hospital Universitario Marques de Valdecilla — Santander
• Hospital Universitario de Jaen — Jaén
• Hospital de La Santa Creu i Sant Pau — Barcelona
• Hospital Universitario HM Sanchinarro - CIOCC — Madrid
• Hospital Universitario Virgen de La Arrixaca — El Palmar
• Clinica Universidad Navarra — Pamplona
• Hospital Universitario de Navarra — Pamplona
• … и ещё 16 центров

США · 14 центров

• Genesis Cancer and Blood Institute (SCRI) — Hot Springs
• Providence Medical Foundation — Fullerton
• Yale Cancer Center — New Haven
• MedStar Georgetown University Hospital — Washington D.C.
• Henry Ford Health System — Detroit
• CentraCare Health — Saint Cloud
• Columbia University Medical Center — New York
• University of Rochester — Rochester
• … и ещё 6 центров

Бельгия · 11 центров

• Imelda VZW — Bonheiden
• Cliniques Universitaires Saint-Luc — Brussels
• Hôpital de Jolimont — La Louvière
• Centre Hospitalier de l'Ardenne — Libramont
• CHU UCL Namur asbl - Site Godinne — Yvoir
• Onze-Lieve-Vrouwziekenhuis — Aalst
• UZ Gent — Ghent
• AZ Groeninge — Kortrijk
• … и ещё 3 центра

Австрия · 10 центров

• Klinikum Klagenfurt Am Woerthersee — Klagenfurt
• Universitätsklinikum St. Pölten — Sankt Pölten
• Ordensklinikum Linz, Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b — Linz
• Pyhrn-Eisenwurzen Klinikum Steyr — Steyr
• Klinikum Wels-Grieskirchen GmbH — Wels
• Landeskrankenhaus Feldkirch — Rankweil
• Kepler Universitätsklinikum Linz — Linz
• Salzburg Cancer Research Institute — Salzburg
• … и ещё 2 центра

Италия · 10 центров

• Ospedale Casa Sollievo Della Sofferenza IRCCS — San Giovanni Rotondo
• Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS — Meldola
• Azienda Unita Sanita Locale di Reggio Emilia IRCCS — Reggio Emilia
• Ospedale San Raffaele S.r.l. - PPDS — Milan
• Instituto Europeo Di Oncologia — Milan
• Ospedale degli Infermi — Candiolo
• Azienda Ospedaliero Universitaria Pisana — Pisa
• Ospedale Santa Maria Della Misericordia Di Perugia — Terni
• … и ещё 2 центра

South Korea · 6 центров

• National Cancer Center — Seoul
• CHA Bundang Medical Center, CHA University — Seoul
• Seoul National University Hospital — Seoul
• Severance Hospital Yonsei University Health System - PPDS — Seoul
• Chonnam National University Hwasun Hospital — Hwasun
• Asan Medical Center - PPDS — Seoul

Австралия · 5 центров

• Canberra Region Cancer Centre — Garran
• The Tweed Hospital — Tweed Heads
• Ashford Cancer Centre Research — Kurralta Park
• Austin Hospital — Heidelberg
• St John of God Murdoch Hospital — Murdoch

Франция · 5 центров

• Hopitaux de La Timone — Marseille
• Centre François Baclesse — Caen
• Hopital Jean Minjoz — Besançon
• Hôpital de Rangueil — Toulouse
• EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS — Rennes

Германия · 5 центров

• Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden
• Charité - Universitätsmedizin Berlin — Berlin
• Asklepios Klinik Altona — Hamburg
• Universitätsklinikum Tübingen — Tübingen
• Klinikum Weiden — Weiden

Великобритания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05254171 · CL-SBP-101-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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