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Trial record 90 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT02117258
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Zeria Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Drug: Z-360 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

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 until the patient fulfills the withdrawal criteria.

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 until the patient fulfills the withdrawal criteria.

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 until the patient fulfills the withdrawal criteria.

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 fulfills the withdrawal criteria.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Approximately 24 months ]
  2. Time to Treatment Failure [ Time Frame: Approximately 24 months ]
  3. Quality of Life [ Time Frame: Approximately 24 months ]
  4. Safety parameters [ Time Frame: Approximately 24 months ]
    Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings

  5. Pharmacokinetics [ Time Frame: Day1 ]
    To characterize the plasma pK of Z-360 when given in combination with GEM

  6. Response Rate [ Time Frame: Approximately 24 months ]
  7. Benefit Rate [ Time Frame: Approximately 24 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117258


Locations
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Japan
Zeria Investigative sites
Japan, Japan
Korea, Republic of
Zeria Investigative Sites
Korea, Korea, Republic of
Taiwan
Zeria Investigative Sites
Taiwan, Taiwan
Sponsors and Collaborators
Zeria Pharmaceutical

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Responsible Party: Zeria Pharmaceutical
ClinicalTrials.gov Identifier: NCT02117258     History of Changes
Other Study ID Numbers: Z-360-01
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Keywords provided by Zeria Pharmaceutical:
Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs