Z-360 Plus GEM In Subjects With Metastatic Pancreatic Adenocarcinoma

Study Overview

Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

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.

N/A

Metastatic Pancreatic Adenocarcinoma

DRUG: Z-360
DRUG: Placebo

Z-360-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-06-29
First Submitted that Met QC Criteria 2014-04-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-07-02
First Posted (ACTUAL) 2014-04-17	Results First Posted N/A	Last Verified 2017-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Z-360 60mg+Gemcitabine Z-360 60 mg will be taken orally, twice daily (BID) after a meal.	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 unt
EXPERIMENTAL: Z-360 120mg+Gemcitabine Z-360 120 mg will be taken orally, twice daily (BID) after a meal.	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 unt
EXPERIMENTAL: Z-360 240mg+Gemcitabine Z-360 240 mg will be taken orally, twice daily (BID) after a meal.	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 unt
PLACEBO_COMPARATOR: Placebo+Gemcitabine Placebo will be taken orally, twice daily (BID) after a meal.	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 ful

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		Approximately 24 months

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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).

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Clinical Trial Record