NCT02117258

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

2.3 years

First QC Date

April 7, 2014

Last Update Submit

June 29, 2017

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Approximately 24 months

Secondary Outcomes (7)

  • Progression Free Survival (PFS)

    Approximately 24 months

  • Time to Treatment Failure

    Approximately 24 months

  • Quality of Life

    Approximately 24 months

  • Safety parameters

    Approximately 24 months

  • Pharmacokinetics

    Day1

  • +2 more secondary outcomes

Study Arms (4)

Z-360 60mg+Gemcitabine

EXPERIMENTAL

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

Drug: Z-360

Z-360 120mg+Gemcitabine

EXPERIMENTAL

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

Drug: Z-360

Z-360 240mg+Gemcitabine

EXPERIMENTAL

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

Drug: Z-360

Placebo+Gemcitabine

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Z-360DRUG

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+GemcitabineZ-360 240mg+GemcitabineZ-360 60mg+Gemcitabine
PlaceboDRUG

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.

Placebo+Gemcitabine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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
  • \. Subjects with a life expectancy of at least 12 weeks,
  • \. Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2,
  • \. 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zeria Investigative sites

Japan, Japan

Location

Zeria Investigative Sites

Korea, South Korea

Location

Zeria Investigative Sites

Dawan, Taiwan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Z-360

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 17, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2016

Study Completion

March 1, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

JP(1)TW(1)KR(1)