Metastatic Pancreatic Adenocarcinoma
Conditions
Keywords
Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma
Brief summary
The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.
Interventions
DRUGZ-360
Gemcitabine (1,000 mg/m\^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while Z-360 (60, 120 or 240 mg) will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.
DRUGPlacebo
Gemcitabine (1,000 mg/m\^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while placebo will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.
Sponsors
Zeria Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Subjects with histological or cytological evidence of metastatic Pancreatic Adenocarcinoma, Measurable disease or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version criteria * 2\. Subjects with a life expectancy of at least 12 weeks, * 3\. Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2, * 4\. Subjects with the following adequate organ functions: * White blood cell count ≥3,000/μL (or absolute neutrophil count ≥1,500/μL) and ≤ 12,000/μL , * Platelet count ≥100.0 × 10\^9/L, * Hemoglobin ≥9.0 g/dL, * Serum creatinine ≤1.5 × the upper limit normal (ULN), * Total bilirubin ≤2.0 × ULN, * Serum aspartate transaminase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases), and * Serum alanine aminotransferase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases).
Exclusion criteria
* Subjects received the following previous therapies for Pancreatic Adenocarcinoma: * Surgery within the 4 weeks prior to randomization, * Radiation and chemoradiation within the 12 weeks prior to randomization, * Radiation for pain relief within the 4 weeks prior to randomization, * Gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization, * Chemotherapy except GEM used as an adjuvant on surgery within the 4 weeks prior to randomization, * Gemcitabine ≥600 mg/m\^2 as sensitizer for chemoradiation, * Gemcitabine \<600 mg/m\^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization, * Gemcitabine used for systemic chemotherapy, or * Systemic chemotherapies except GEM within the 4 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Approximately 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure | Approximately 24 months | — |
| Quality of Life | Approximately 24 months | — |
| Safety parameters | Approximately 24 months | Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings |
| Progression Free Survival (PFS) | Approximately 24 months | — |
| Response Rate | Approximately 24 months | — |
| Benefit Rate | Approximately 24 months | — |
| Pharmacokinetics | Day1 | To characterize the plasma pK of Z-360 when given in combination with GEM |
Countries
Japan, South Korea, Taiwan
Outcome results
None listed