Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-26 @ 11:14 AM
Study NCT ID:
NCT02117258
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2014-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C528831', 'term': 'Z-360'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Approximately 24 months'}], 'secondaryOutcomes': [{'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', 'description': 'Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Day1', 'description': 'To characterize the plasma pK of Z-360 when given in combination with GEM'}, {'measure': 'Response Rate', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Benefit Rate', 'timeFrame': 'Approximately 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma'], 'conditions': ['Metastatic Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 2\\. Subjects with a life expectancy of at least 12 weeks,\n* 3\\. Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2,\n* 4\\. Subjects with the following adequate organ functions:\n\n * White blood cell count ≥3,000/μL (or absolute neutrophil count ≥1,500/μL) and ≤ 12,000/μL ,\n * Platelet count ≥100.0 × 10\\^9/L,\n * Hemoglobin ≥9.0 g/dL,\n * Serum creatinine ≤1.5 × the upper limit normal (ULN),\n * Total bilirubin ≤2.0 × ULN,\n * Serum aspartate transaminase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases), and\n * Serum alanine aminotransferase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases).\n\nExclusion Criteria:\n\n* Subjects received the following previous therapies for Pancreatic Adenocarcinoma:\n\n * Surgery within the 4 weeks prior to randomization,\n * Radiation and chemoradiation within the 12 weeks prior to randomization,\n * Radiation for pain relief within the 4 weeks prior to randomization,\n * Gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization,\n * Chemotherapy except GEM used as an adjuvant on surgery within the 4 weeks prior to randomization,\n * Gemcitabine ≥600 mg/m\\^2 as sensitizer for chemoradiation,\n * Gemcitabine \\<600 mg/m\\^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization,\n * Gemcitabine used for systemic chemotherapy, or\n * Systemic chemotherapies except GEM within the 4 weeks prior to randomization.'}, 'identificationModule': {'nctId': 'NCT02117258', 'acronym': 'ZIPANG', 'briefTitle': 'Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeria Pharmaceutical'}, 'officialTitle': 'Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )', 'orgStudyIdInfo': {'id': 'Z-360-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Z-360 60mg+Gemcitabine', 'description': 'Z-360 60 mg will be taken orally, twice daily (BID) after a meal.', 'interventionNames': ['Drug: Z-360']}, {'type': 'EXPERIMENTAL', 'label': 'Z-360 120mg+Gemcitabine', 'description': 'Z-360 120 mg will be taken orally, twice daily (BID) after a meal.', 'interventionNames': ['Drug: Z-360']}, {'type': 'EXPERIMENTAL', 'label': 'Z-360 240mg+Gemcitabine', 'description': 'Z-360 240 mg will be taken orally, twice daily (BID) after a meal.', 'interventionNames': ['Drug: Z-360']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+Gemcitabine', 'description': 'Placebo will be taken orally, twice daily (BID) after a meal.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Z-360', 'type': 'DRUG', '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.', 'armGroupLabels': ['Z-360 120mg+Gemcitabine', 'Z-360 240mg+Gemcitabine', 'Z-360 60mg+Gemcitabine']}, {'name': 'Placebo', 'type': 'DRUG', '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.', 'armGroupLabels': ['Placebo+Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Japan', 'country': 'Japan', 'facility': 'Zeria Investigative sites'}, {'city': 'Korea', 'country': 'South Korea', 'facility': 'Zeria Investigative Sites'}, {'city': 'Dawan', 'country': 'Taiwan', 'facility': 'Zeria Investigative Sites', 'geoPoint': {'lat': 23.20917, 'lon': 120.18722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeria Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}