Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02278458
Status:
UNKNOWN
Last Update Posted:
2015-05-22
First Post:
2014-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer
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': 'C531470', 'term': 'icotinib'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2014-10-28', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients who suffer adverse events', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Tumor response assessed by RECIST 1.1', 'timeFrame': '3 months'}, {'measure': 'Progression-free survival', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.\n* ECOG Performance Status of 0 to 1.\n* Adequate organ function as defined by study-specified laboratory tests.\n* Signed informed consent form.\n* Willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n* Previous chemotherapy or target therapy.\n* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.\n* Systemically active steroids.\n* Another investigational product within 28 days prior to receiving study drug.\n* Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.\n* Infection with HIV, hepatitis B or C at screening.\n* Pregnant or lactating.\n* Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures."}, 'identificationModule': {'nctId': 'NCT02278458', 'briefTitle': 'Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Betta Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'BD-IC-IV70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'icotinib plus gemcitabine', 'description': 'Three dose of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.\n\nGemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.', 'interventionNames': ['Drug: icotinib', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'icotinib', 'type': 'DRUG', 'otherNames': ['Commana'], 'description': 'Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.', 'armGroupLabels': ['icotinib plus gemcitabine']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.', 'armGroupLabels': ['icotinib plus gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Cancer Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '150081', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Bethune First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '150081', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Yanqiao Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital of Harbin Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}