A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer

Официальное название

A First-in-Human, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ACT Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine (ACT-IOP-003) Once Weekly or Twice Weekly Following First-Line Systemic Chemotherapy in Participants With Nonresectable Pancreatic Cancer

Обзор

This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable. The main questions the study aims to answer are: * Is ACT-IOP-003 safe and tolerable when given to patients with nonmetastatic, locally advanced, nonresectable pancreatic cancer. * How much study drug (gemcitabine) is found in the blood before and after treatment. * If the tumor responds to treatment. * If the gemcitabine side effects are less than seen when delivered intravenously (IV). Study participants will: * Have the study device surgically placed on the pancreas at the beginning of the study. * Complete 8 weeks of treatment with a 4 week screening period and 12 weeks of follow-up for a total of 24 weeks of participation in the study. * Give blood, urine, and stool samples to monitor safety and determine how much of the study drug (gemcitabine) is in the blood. * Have imaging (CT) done at least three times during the study.

Вмешательства

• Комбинированный продукт ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
  The investigational product, ACT-IOP-003, is an ACT implantable iontophoresis chemotherapy delivery device that delivers gemcitabine directly to the pancreas instead of through intravenous (IV) infusion into the blood stream.

Первичные конечные точки

• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [Срок оценки: Screening through Week 20]
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [Срок оценки: Screening through Week 20]
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [Срок оценки: Screening through Week 20]
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [Срок оценки: Screening through Week 20]
• Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting [Срок оценки: Screening through Week 20]

Вторичные конечные точки (7)

• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose [Срок оценки: Screening through Week 8]
• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose [Срок оценки: Screening through Week 8]
• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose [Срок оценки: Screening through Week 8]
• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose [Срок оценки: Screening through Week 8]
• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose [Срок оценки: Screening through Week 8]
• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose [Срок оценки: Screening through Week 8]
• Plasma Pharmacokinetic (PK) Concentrations Assessed by Plasma PK of Gemcitabine Pre- and Post-dose [Срок оценки: Screening through Week 8]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Diagnosis of nonmetastatic, nonresectable pancreatic adenocarcinoma as evident on initial study. screening computed tomography (CT) or magnetic resonance imaging (MRI) or previous scan within the last 12 weeks.
• Initial diagnosis of borderline or locally advanced pancreatic adenocarcinoma confirmed as being nonresectable at the time of exploratory laparoscopic and/ or open surgery.
• Previously received prior standard of care/neoadjuvant chemotherapy of FOLFIRINOX or GEM Abraxane for their current diagnosis of pancreatic cancer.

Критерии исключения

• Current pancreatitis classified as severe or critical.
• Prior radiation treatment as part of standard of care/neoadjuvant treatment for pancreatic cancer.
• Evidence of metastatic pancreatic cancer or any other type of cancer upon screening of through CT/MRI.
• Any medical history of past or present cardiovascular disease related to heart function.
• Any metal implants.

Note: Other inclusion/exclusion criteria apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Michigan Health — Ann Arbor
• West Virginia University — Morgantown

Идентификаторы

NCT: NCT07481383 · ACT-IOP-003-CLN-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗