Status:
NOT_YET_RECRUITING
A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer
Lead Sponsor:
Rgene Corporation
Collaborating Sponsors:
American BriVision Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.The secondary purpose i...
Eligibility Criteria
Inclusion
- Patients aged 20 - 80 years old at the time of signing the ICF.
- Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant gemcitabine are acceptable, unless exclusion criteria met).
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 to 2.
- Adequate hematologic function defined as: absolute neutrophil count (ANC) \>= 2,000/μL; platelets count \>= 100,000/μL; hemoglobin must be \>= 10 g/dL (can be corrected by growth factor or transfusion).
- Adequate hepatic function defined as: serum bilirubin =\< 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =\< 3-fold ULN (5-fold ULN if liver metastasis is observed).
- Adequate renal function with: serum creatinine =\< 1.3 mg/dL or calculated creatinine clearance \>= 60 mL/minute according to the Cockcroft and Gault formula.
- At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.
- Planning to receive Gemcitabine monotherapy.
- Willing and able to comply with all aspects of the treatment protocol.
- Provide written informed consent.
Exclusion
- Patients with following treatment prior to Gemcitabine monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 28 days of study entry.
- Pancreatic patients with prior history of Gemcitabine chemotherapy.
- Women who are pregnant or breastfeeding.
- Patients with brain metastasis.
- Patients with bone metastasis alone.
- Patients with autoimmune disease that requires systemic steroids or immunosuppression agents.
- Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
- Known history of human immunodeficiency virus (HIV) infection.
- Existing anticancer treatment-related toxicities of Grades \>= 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
- Patients with an active infection requiring systemic therapy.
- Patients are hepatitis C virus (HCV) carrier, and/or with active viral disease which is defined as hepatitis B virus (HBV) carrier with HBV DNA \> 2,000 IU/ml plus AST and ALT \> 3-fold ULN.
- History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the patient's ability to safely complete the study.
- Ascertained hypersensitivity to investigational product, Gemcitabine or any of the excipients used in the study.
- Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment.
- Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03301805
Start Date
July 1 2025
End Date
June 30 2027
Last Update
August 9 2024
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