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Clinical Trial Record

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

2025-07-01

2027-04-30

2027-06-30

40

Study Overview

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

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.

N/A

  • Pancreatic Cancer
  • DRUG: BLEX 404
  • RGC-1502-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2017-09-29  

N/A  

2024-08-07  

2017-09-29  

N/A  

2024-08-09  

2017-10-04  

N/A  

2024-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: BLEX 404 Oral Liquid

During Phase I study (dose escalation), a standard 3+3 design will be followed, and the dose range is 3 to 10 mg/kg BID. The recommended dose level (RDL) for the Phase II study is defined as the dose level with 0 to 1 DLT observed during cycle I of Gemcit

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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Part I: Dose-limiting toxicity (DLT) observationPresence 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)
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 Outcome MeasuresMeasure DescriptionTime Frame
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)
Part II: Incidence of grade 3/4 hematological toxicityRate of grade 3/4 hematological toxicity of each cycle.4 weeks (1 cycle)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Frank C. Liu

Phone Number: +886-2-87518701

Email: liu3763@bioliteinc.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • American BriVision Corporation
  • PRINCIPAL_INVESTIGATOR: Gi-Ming Lai, M.D., Taipei Municipal Wanfang Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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