Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

Overview

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.

Full Title of Study: “Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2016

Interventions

  • Drug: Z-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.
  • Drug: Placebo
    • 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.

Arms, Groups and Cohorts

  • Experimental: Z-360 60mg+Gemcitabine
    • Z-360 60 mg will be taken orally, twice daily (BID) after a meal.
  • Experimental: Z-360 120mg+Gemcitabine
    • Z-360 120 mg will be taken orally, twice daily (BID) after a meal.
  • Experimental: Z-360 240mg+Gemcitabine
    • Z-360 240 mg will be taken orally, twice daily (BID) after a meal.
  • Placebo Comparator: Placebo+Gemcitabine
    • Placebo will be taken orally, twice daily (BID) after a meal.

Clinical Trial Outcome Measures

Primary Measures

  • Overall Survival
    • Time Frame: Approximately 24 months

Secondary Measures

  • Progression Free Survival (PFS)
    • Time Frame: Approximately 24 months
  • Time to Treatment Failure
    • Time Frame: Approximately 24 months
  • Quality of Life
    • Time Frame: Approximately 24 months
  • Safety parameters
    • Time Frame: Approximately 24 months
    • Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings
  • Pharmacokinetics
    • Time Frame: Day1
    • To characterize the plasma pK of Z-360 when given in combination with GEM
  • Response Rate
    • Time Frame: Approximately 24 months
  • Benefit Rate
    • Time Frame: Approximately 24 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zeria Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor

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