Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer

Официальное название

A Single Center, Open-label, Non-comparative, Phase I/II Clinical Trial to Assess the MTD, Safety and Efficacy of BEY1107 in Monotherapy and in Combination with Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer

Обзор

This study is a single center, open-label, non-comparative, phase I/II clinical trial to assess the maximum tolerated dose (MTD), safety and efficacy of BEY1107 in monotherapy and in combination with gemcitabine in patient With locally advanced or metastatic pancreatic cancer.

Подробное описание

The key purpose of the main part of the study is to assess the MTD, safety and efficacy of BEY1107 as monotherapy and combination therapy for locally advanced and/or metastatic pancreatic cancer. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of BEY1107, to determine the MTD.

Patient will receive BEY1107 for 4 weeks in monotherapy for each cohort (administered in a 3-weeks-on / 1-week-off) during Phase I-1 trial.

At next stage, patient will receive BEY1107 with gemcitabine for 4weeks in phase I-2 trial.

Final stage, patient will receive BEY1107 with gemcitabine for 24weeks in phase II trial.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival of fresh biopsy tissue will also be collected for biomarker analysis.

Вмешательства

• Препарат BEY1107
  Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.
• Комбинированный продукт Gemcitabine
  Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.

Первичные конечные точки

• MTD & Safety assessment (Phase I) [Срок оценки: 0]
• DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II) [Срок оценки: 0]

Вторичные конечные точки (5)

• AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I) [Срок оценки: 0]
• Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I) [Срок оценки: 0]
• DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I) [Срок оценки: 0]
• ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II) [Срок оценки: 0]
• Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II) [Срок оценки: 0]

Критерии участия

Критерии включения

• Histologically or Cytologically confirmed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
• At lease one measurable lesion according to RECIST v.1.1
• Eastern Cooperative Oncology Group (ECOG) 0,1 or 2
• Over 12 weeks of Life expectancy
• Adequate Bone marrow, Renal and Liver function at screening

Критерии исключения

• A patient who has treatment history with locally advanced and/or metastatic pancreatic cancer
• Major surgery history at screening
• Uncontrolled brain metastasis evidence
• Active bacterial infection patients
• Malignant tumor other than basal cell carcinoma, cervix carcinoma in situ and papillary thyroid cancer
• expected Pregnant or breast-feeding patients
• HIV, Active hepatitis B or C infection
• A patient who has hypersensitivity with BEY1107 or Gemcitabine

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

South Korea · 1 центр

• Yonsei University Health System Severance Hospital — Seoul

Идентификаторы

NCT: NCT03579836 · BEY-2018-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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