Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma (ZIPANG)

Zeria Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Adenocarcinoma

Treatments: Drug: Placebo; Drug: Z-360

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117258

Z-360-01

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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167 participants in 4 patient groups, including a placebo group

Z-360 60mg+Gemcitabine

Experimental group

Description:

Z-360 60 mg will be taken orally, twice daily (BID) after a meal.

Treatment:

Drug: Z-360

Z-360 120mg+Gemcitabine

Experimental group

Description:

Z-360 120 mg will be taken orally, twice daily (BID) after a meal.

Treatment:

Drug: Z-360

Z-360 240mg+Gemcitabine

Experimental group

Description:

Z-360 240 mg will be taken orally, twice daily (BID) after a meal.

Treatment:

Drug: Z-360

Placebo+Gemcitabine

Placebo Comparator group

Description:

Placebo will be taken orally, twice daily (BID) after a meal.

Treatment:

Drug: Placebo