Clinical trial · Interventional
Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma
Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )
NCT02117258CI-TRIAL-00028348ZIPANGcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Z-360 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Z-360 60mg+Gemcitabine
- description
- Z-360 60 mg will be taken orally, twice daily (BID) after a meal.
- interventionNames
- Drug: Z-360
- type
- EXPERIMENTAL
- label
- Z-360 120mg+Gemcitabine
- description
- Z-360 120 mg will be taken orally, twice daily (BID) after a meal.
- interventionNames
- Drug: Z-360
- type
- EXPERIMENTAL
- label
- Z-360 240mg+Gemcitabine
- description
- Z-360 240 mg will be taken orally, twice daily (BID) after a meal.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.