Pancreatic Cancer
Conditions
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 is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.
Interventions
DRUGBLEX 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.
Sponsors
Rgene Corporation
American BriVision Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study Objectives Part I To determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule. Part II To assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part I: Dose-limiting toxicity (DLT) observation | 4 weeks (1 cycle) | 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). |
| Part II: Overall response rate (PR + CR) | 12 weeks (3 cycle) | Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Gemcitabine monotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part II: Overall benefit rate (CR + PR + SD) | 12 weeks (3 cycle) | 1\. Overall benefit rate (CR + PR + SD) after at least 3 cycles of combination use of BLEX 404 plus Gemcitabine monotherapy. |
| Part II: Incidence of grade 3/4 hematological toxicity | 4 weeks (1 cycle) | Rate of grade 3/4 hematological toxicity of each cycle. |
Contacts
CONTACTFrank C. Liu
PRINCIPAL_INVESTIGATORGi-Ming Lai, M.D.
Taipei Municipal Wanfang Hospital
Outcome results
None listed