Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zeria Pharmaceutical
• Treatments: Gemcitabine

Criteria

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.