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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03301805
Other study ID # RGC-1502-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2024
Est. completion date June 30, 2026

Study information

Verified date November 2023
Source Rgene Corporation
Contact Frank C. Liu
Phone +886-2-87518701
Email liu3763@bioliteinc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BLEX 404
BLEX 404 Oral Liquid is administered twice daily during the Gemcitabine monotherapy period. The dose of Gemcitabine 1,000 mg/m2 IV fusion at Day 1, 8, 15 of every cycle 28 days a cycle.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Rgene Corporation American BriVision Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary Part I: Dose-limiting toxicity (DLT) observation Presence or absence of dose-limiting toxicity (DLT) related to BLEX 404 Oral Liquid for each patient during first cycle of Gemcitabine monotherapy to determine the recommended dose level (RDL). 4 weeks (1 cycle)
Primary Part II: Overall response rate (PR + CR) Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Gemcitabine monotherapy. 12 weeks (3 cycle)
Secondary Part II: Overall benefit rate (CR + PR + SD) 1. Overall benefit rate (CR + PR + SD) after at least 3 cycles of combination use of BLEX 404 plus Gemcitabine monotherapy. 12 weeks (3 cycle)
Secondary Part II: Incidence of grade 3/4 hematological toxicity Rate of grade 3/4 hematological toxicity of each cycle. 4 weeks (1 cycle)
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