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

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Z-360

Placebo

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma focused on measuring Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Zeria Investigative sites
Zeria Investigative Sites
Zeria Investigative Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Z-360 60mg+Gemcitabine

Z-360 120mg+Gemcitabine

Z-360 240mg+Gemcitabine

Placebo+Gemcitabine

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression Free Survival (PFS)

Time to Treatment Failure

Quality of Life

Safety parameters

Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings

Pharmacokinetics

To characterize the plasma pK of Z-360 when given in combination with GEM

Response Rate

Benefit Rate

Full Information

NCT ID

NCT02117258

First Posted

April 7, 2014

Last Updated

June 29, 2017

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02117258

Brief Title

Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

Acronym

ZIPANG

Official Title

Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Pancreatic Adenocarcinoma

Keywords

Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Z-360 60mg+Gemcitabine

Arm Type

Experimental

Arm Description

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

Arm Title

Z-360 120mg+Gemcitabine

Arm Type

Experimental

Arm Description

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

Arm Title

Z-360 240mg+Gemcitabine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo+Gemcitabine

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Z-360

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Overall Survival

Time Frame

Approximately 24 months

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Time Frame

Approximately 24 months

Title

Time to Treatment Failure

Time Frame

Approximately 24 months

Title

Quality of Life

Time Frame

Approximately 24 months

Title

Safety parameters

Description

Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings

Time Frame

Approximately 24 months

Title

Pharmacokinetics

Description

To characterize the plasma pK of Z-360 when given in combination with GEM

Time Frame

Day1

Title

Response Rate

Time Frame

Approximately 24 months

Title

Benefit Rate

Time Frame

Approximately 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Zeria Investigative sites

City

Japan

Country

Japan

Facility Name

Zeria Investigative Sites

City

Korea

Country

Korea, Republic of

Facility Name

Zeria Investigative Sites

City

Taiwan

Country

Taiwan

12. IPD Sharing Statement

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Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

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