Overview

This trial is active, not recruiting.

Condition metastatic pancreatic adenocarcinoma
Treatments z-360, placebo
Phase phase 2
Sponsor Zeria Pharmaceutical
Start date April 2014
End date July 2016
Trial size 160 participants
Trial identifier NCT02117258, Z-360-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Z-360 60 mg will be taken orally, twice daily (BID) after a meal.
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.
(Experimental)
Z-360 120 mg will be taken orally, twice daily (BID) after a meal.
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.
(Experimental)
Z-360 240 mg will be taken orally, twice daily (BID) after a meal.
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.
(Placebo Comparator)
Placebo will be taken orally, twice daily (BID) after a meal.
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.

Primary Outcomes

Measure
Overall Survival
time frame: Approximately 24 months

Secondary Outcomes

Measure
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
Pharmacokinetics
time frame: Day1
Response Rate
time frame: Approximately 24 months
Benefit Rate
time frame: Approximately 24 months

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Zeria Pharmaceutical.