Metastatic Pancreatic Adenocarcinoma Clinical Trial
— ZIPANGOfficial title:
Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )
Verified date | June 2017 |
Source | Zeria Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 167 |
Est. completion date | March 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Japan | Zeria Investigative sites | Japan | |
Korea, Republic of | Zeria Investigative Sites | Korea | |
Taiwan | Zeria Investigative Sites | Taiwan |
Lead Sponsor | Collaborator |
---|---|
Zeria Pharmaceutical |
Japan, Korea, Republic of, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Approximately 24 months | ||
Secondary | Progression Free Survival (PFS) | Approximately 24 months | ||
Secondary | Time to Treatment Failure | Approximately 24 months | ||
Secondary | Quality of Life | Approximately 24 months | ||
Secondary | Safety parameters | Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings | Approximately 24 months | |
Secondary | Pharmacokinetics | To characterize the plasma pK of Z-360 when given in combination with GEM | Day1 | |
Secondary | Response Rate | Approximately 24 months | ||
Secondary | Benefit Rate | Approximately 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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