Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-01-29 @ 3:35 PM
Study NCT ID:
NCT03620461
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2018-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine and Nabpaclitaxel in Metastatic Pancreatic Carcinoma.
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 years', 'description': 'Evaluate overall survival (OS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel'}, {'measure': 'progression free survival', 'timeFrame': '2 years', 'description': 'Evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer receiving gemcitabine and nab-paclitaxel'}, {'measure': 'Assess adverse events (per CTCAE v4.0 criteria)', 'timeFrame': '2 years', 'description': 'Assess the adverse events (per CTCAE v4.0 criteria) associated with the use of gemcitabine and nab-paclitaxel in real world setting.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metastatic pancreatic cancer', 'real world data', 'gemcitabine', 'nabpaclitaxel', 'efficacy', 'safety'], 'conditions': ['Metastatic Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Retrospective, multicenter study including pts with metastatic pancreatic cancer who started first-line treatment with napaclitaxel plus Gemcitabine between December 2013 and June 2015 according to the routine practice. Overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on treatment and clinical characteristics of the study pts.', 'detailedDescription': "This observational, retrospective, multicenter study included patients with metastatic pancreatic adenocarcinoma (either recurrent or de novo) from 20 Spanish hospitals, who started first-line chemotherapy with nab-paclitaxel (Abraxane®, Celgene Europe Limited) plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. The record included all adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,\\[15\\] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine. Data were retrieved from patients' medical records and lasted until death or the closure of the database on 16 March 2017. All patients signed the corresponding informed consent for their clinical data being used in this study, which was conducted in accordance with the local personal data protection law (LOPD 15/1999). The study protocol was approved by the local independent ethics committee."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1,\\[15\\] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma that is metastatic to distant sites.\n* Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.\n* No prior chemotherapy for metastatic pancreatic cancer.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.\n* Age greater than or equal to 18 years.\n* Patient has signed a Patient Informed Consent Form.\n* Patients should have received at least one cycle of gemcitabine and nabpaclitaxel\n\nExclusion Criteria:\n\n* less than one cycle of gemcitabine/nabpaclitaxel administrated.'}, 'identificationModule': {'nctId': 'NCT03620461', 'acronym': 'ANICE-PaC', 'briefTitle': 'Gemcitabine and Nabpaclitaxel in Metastatic Pancreatic Carcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'Galician Research Group on Digestive Tumors'}, 'officialTitle': 'Epidemiological, Observational, Retrospective and Multicenter Study to Evaluate the Characteristics of Treatment With Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Adenocarcinoma Treated in the First Line in Routine Clinical Practice. ANICE-PaC Study', 'orgStudyIdInfo': {'id': 'gitud'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gemcitabine - nabpaclitaxel', 'type': 'DRUG', 'description': 'efficacy and safety'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galician Research Group on Digestive Tumors', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}