Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

Phase 2

Completed

• Conditions: Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: Z-360; Drug: Placebo

• Registration Number: NCT02117258
• Lead Sponsor: Zeria Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Primary Completion: 2016-07
• Study Completion: 2017-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Z-360 60mg+Gemcitabine	Z-360	Z-360 60 mg will be taken orally, twice daily (BID) after a meal.
Placebo+Gemcitabine	Placebo	Placebo will be taken orally, twice daily (BID) after a meal.
Z-360 120mg+Gemcitabine	Z-360	Z-360 120 mg will be taken orally, twice daily (BID) after a meal.
Z-360 240mg+Gemcitabine	Z-360	Z-360 240 mg will be taken orally, twice daily (BID) after a meal.

Primary Outcome Measures

Name	Time	Method
Overall Survival	Approximately 24 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Approximately 24 months
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
Pharmacokinetics	Day1	To characterize the plasma pK of Z-360 when given in combination with GEM
Response Rate	Approximately 24 months
Benefit Rate	Approximately 24 months

Trial Locations

Locations (2)

Zeria Investigative sites; 🇯🇵 Japan, Japan

Zeria Investigative Sites; 🇨🇳 Taiwan, Taiwan