Overview

A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer

Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
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 is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rgene Corporation
Treatments:
Gemcitabine
Criteria
Inclusion Criteria:

1. Patients aged 20 - 80 years old at the time of signing the ICF.

2. 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).

3. Eastern Cooperative Oncology Group (ECOG) performance status of 1 to 2.

4. 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).

5. 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).

6. Adequate renal function with: serum creatinine =< 1.3 mg/dL or calculated creatinine
clearance >= 60 mL/minute according to the Cockcroft and Gault formula.

7. At least one measurable disease according to the Response Evaluation Criteria in Solid
Tumors (RECIST) version 1.1.

8. 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.

9. Planning to receive Gemcitabine monotherapy.

10. Willing and able to comply with all aspects of the treatment protocol.

11. Provide written informed consent.

Exclusion Criteria:

1. Patients with following treatment prior to Gemcitabine monotherapy: chemotherapy,
immunotherapy, or biologic systemic anticancer therapy within 28 days of study entry.

2. Pancreatic patients with prior history of Gemcitabine chemotherapy.

3. Women who are pregnant or breastfeeding.

4. Patients with brain metastasis.

5. Patients with bone metastasis alone.

6. Patients with autoimmune disease that requires systemic steroids or immunosuppression
agents.

7. Current enrollment in another clinical study or used any investigational drug or
device within the past 28 days preceding informed consent.

8. Known history of human immunodeficiency virus (HIV) infection.

9. Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia
and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE
v4.03).

10. Patients with an active infection requiring systemic therapy.

11. 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.

12. 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.

13. Ascertained hypersensitivity to investigational product, Gemcitabine or any of the
excipients used in the study.

14. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to
comply with daily BLEX 404 Oral Liquid treatment.

15. 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.