Trial | NCT03579836  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    75
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.
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.
Study Started
May 01
2018
Primary Completion
Mar 31
2021
Anticipated
Study Completion
Oct 31
2021
Anticipated
Last Update
Jul 25
2019

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.

Phase I-1 (#4 Cohort) Experimental

BEY1107 monotherapy, 4 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)

Phase I-2 (#3 Cohort) Experimental

BEY1107 in combination with Gemcitabine, 3 Cohorts, 4 weeks (administered on a 3-week-on and 1-week-off)

Phase II (#1 Cohort) Experimental

BEY1107 in combination with Gemcitabine, 6 Cycles / 24 weeks (administered on a 3-week-on and 1-week-off)

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
No Results Posted