Clinical trial NCT02117258: Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Adenocarcinoma
Keywords: Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 167
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Survival
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Approximately 24 months
measure: Time to Treatment Failure
timeFrame: Approximately 24 months
measure: Quality of Life
timeFrame: Approximately 24 months
measure: Safety parameters
timeFrame: Approximately 24 months
measure: Pharmacokinetics
timeFrame: Day1
measure: Response Rate
timeFrame: Approximately 24 months
measure: Benefit Rate
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Zeria Investigative sites
city: Korea
country: Korea, Republic of
facility: Zeria Investigative Sites
city: Taiwan
country: Taiwan
facility: Zeria Investigative Sites
Study officials:
References: