Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

NCT ID: NCT02117258

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-03-31

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Z-360 60mg+Gemcitabine

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

Group Type: EXPERIMENTAL

Z-360

Intervention Type: DRUG

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.

Z-360 120mg+Gemcitabine

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

Group Type: EXPERIMENTAL

Z-360

Intervention Type: DRUG

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.

Z-360 240mg+Gemcitabine

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

Group Type: EXPERIMENTAL

Z-360

Intervention Type: DRUG

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.

Placebo+Gemcitabine

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeria Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zeria Investigative sites

Japan, , Japan

Zeria Investigative Sites

Korea, , South Korea

Zeria Investigative Sites

Dawan, , Taiwan

Countries

Japan; South Korea; Taiwan

Other Identifiers

Z-360-01

Identifier Type: -

Identifier Source: org_study_id