Evaluation of Safety and Efficacy in BEY1107 in Monotherapy Gemcitabine Combination in Patient with Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BEY1107, Gemcitabine.
- Who it may be relevant to
- Registry conditions: Locally Advanced or Metastatic Pancreatic Cancer. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug BEY1107
Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule. - Combination product Gemcitabine
Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.
Primary outcome measures
- MTD & Safety assessment (Phase I) [Time frame: 0]
- DCR(Disease Control Rate) in combination therapy of BEY1107 and Gemcitabine (Phase II) [Time frame: 0]
Secondary outcome measures (5)
- AUC in BEY1107 monotherapy and Gemcitabine combination (Phase I) [Time frame: 0]
- Cmax in BEY1107 monotherapy and Gemcitabine combination (Phase I) [Time frame: 0]
- DCR(Disease Control Rate) in BEY1107 monotherapy and Gemcitabine combination (Phase I) [Time frame: 0]
- ORR(Objective Response Rate) in BEY1107 and Gemcitabine combination (Phase II) [Time frame: 0]
- Number of subjects with Adverse events in BEY1107 and Gemcitabine combination (Phase II) [Time frame: 0]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei University Health System Severance Hospital — Seoul
Identifiers
NCT: NCT03579836 · BEY-2018-01