Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma Clinical Trial

— ZIPANG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117258
• Other study ID #: Z-360-01
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2014
• Last updated: June 29, 2017
• Start date: April 2014
• Est. completion date: March 2017

Study information

• Verified date: June 2017
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma

Intervention

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 until the patient fulfills the withdrawal criteria.
• 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.

Locations

Country	Name	City	State
Japan	Zeria Investigative sites	Japan
Korea, Republic of	Zeria Investigative Sites	Korea
Taiwan	Zeria Investigative Sites	Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

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