Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-17 @ 7:32 AM
Study NCT ID:
NCT02021500
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
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': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2015-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'up to 3 years', 'description': 'Number of participants who survive'}], 'secondaryOutcomes': [{'measure': 'Disease progression', 'timeFrame': 'up to 3 years', 'description': 'Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '26802153', 'type': 'BACKGROUND', 'citation': 'Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.'}, {'pmid': '26802160', 'type': 'BACKGROUND', 'citation': 'Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.'}, {'pmid': '26655559', 'type': 'BACKGROUND', 'citation': 'Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.'}, {'pmid': '26372701', 'type': 'BACKGROUND', 'citation': 'Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.'}, {'pmid': '25638248', 'type': 'BACKGROUND', 'citation': 'Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.'}, {'pmid': '25398812', 'type': 'BACKGROUND', 'citation': 'Vogel A, Pelzer U, Salah-Eddin AB, Koster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.'}, {'pmid': '24131140', 'type': 'BACKGROUND', 'citation': 'Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.'}, {'pmid': '24523592', 'type': 'BACKGROUND', 'citation': 'Al-Hajeili M, Azmi AS, Choi M. Nab-paclitaxel: potential for the treatment of advanced pancreatic cancer. Onco Targets Ther. 2014 Feb 4;7:187-92. doi: 10.2147/OTT.S40705. eCollection 2014.'}, {'pmid': '25582141', 'type': 'BACKGROUND', 'citation': 'Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.'}, {'pmid': '27351217', 'type': 'BACKGROUND', 'citation': 'Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28.'}, {'pmid': '27085323', 'type': 'BACKGROUND', 'citation': 'Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16.'}, {'pmid': '27284481', 'type': 'BACKGROUND', 'citation': 'Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.'}, {'pmid': '27769210', 'type': 'BACKGROUND', 'citation': 'Vogel A, Rommler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817. doi: 10.1186/s12885-016-2798-8.'}, {'pmid': '28203092', 'type': 'BACKGROUND', 'citation': 'Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.'}, {'pmid': '27841795', 'type': 'BACKGROUND', 'citation': 'Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.'}]}, 'descriptionModule': {'briefSummary': 'A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.', 'detailedDescription': 'A study to collect survival status of CA046 subjects who were know to be alive at the last report of vital status for CA046 - approximate timeframe - end of March, 2013. Once consent is given, on a quarterly basis, information on status will be collected to include:\n\n* Vital Status\n* Date of disease progression\n* Subsequent anticancer therapy for pancreatic adenocarcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients previously enrolled in study CA046', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have been enrolled in the CA046 study Must have been living at the time of the last survival follow-up (approximate timeframe - end of March, 2013) Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data)\n\nExclusion Criteria:\n\n* Consent refused for any reason'}, 'identificationModule': {'nctId': 'NCT02021500', 'briefTitle': 'A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046', 'orgStudyIdInfo': {'id': 'ABI-007-PANC-CA046C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients previously enrolled in study CA046', 'description': 'No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)', 'interventionNames': ['Drug: ABI-007']}], 'interventions': [{'name': 'ABI-007', 'type': 'DRUG', 'description': 'No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)', 'armGroupLabels': ['Patients previously enrolled in study CA046']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'TGen Clinical Research Services', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Shores Medical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '34223', 'city': 'Englewood', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.96201, 'lon': -82.3526}}, {'zip': '32778', 'city': 'Tavares', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialist', 'geoPoint': {'lat': 28.80416, 'lon': -81.72563}}, {'zip': '46202-5149', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Arena Oncology Associates', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Pavillion', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Oncology and Hematology (STOH)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22033', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fairfax-Northern Virginia Haematology-Oncology', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert and Medical College ID Clinic', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2560', 'city': 'Campbelltown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Macarthur Cancer Therapy Centre', 'geoPoint': {'lat': -34.06667, 'lon': 150.81667}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'country': 'Australia', 'facility': 'HOCA - the Wesley Clinic for Heamatology and Oncology', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '4101', 'city': 'South Brisbane', 'country': 'Australia', 'facility': 'Mater Medical Center', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Landesklinikum St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Klinikum Wels-Grieskirchen GmbH', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L4M6M2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Royal Victoria Regional Health Centre', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospsitalier Universitaire de Montreal - Notre Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'Kliniken Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '81377:', 'city': 'München', 'country': 'Germany', 'facility': 'LMU Klinikum der Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele S.r.l.', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Niguarda Cà Granda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '71013', 'city': 'San Giovanni Rotundo', 'country': 'Italy', 'facility': 'Ospedale Casa Sollievo Della Sofferenza IRCCS'}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata Di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '49102', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Municipal institution Multifield City Clinical Hospital #4 of Dnipropetrovsk Regional Council', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}], 'overallOfficials': [{'name': 'Victoria Manax, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celgene'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}