Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT00550004
Status:
TERMINATED
Last Update Posted:
2011-06-08
First Post:
2007-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 153}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2007-10-25', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '14 months'}, {'measure': 'Evaluate the CA 19-9 levels', 'timeFrame': '12 months'}, {'measure': 'Compare changes in ECOG', 'timeFrame': '12 months'}, {'measure': 'Evaluate Safety of RP101', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Unresectable', 'locally advanced', 'metastatic pancreatic adenocarcinoma', 'Stage III', 'Stage IV'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '21833720', 'type': 'DERIVED', 'citation': 'Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.'}], 'seeAlsoLinks': [{'url': 'http://www.sciclone.com', 'label': 'SciClone Website'}]}, 'descriptionModule': {'briefSummary': 'This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be 18 years of age or older\n* Not previously treated with chemotherapy for Pancreatic Cancer\n* ECOG performance status of 0 or 1\n* Life expectancy \\> 3 months\n* Documentation of all sites of pancreatic disease within 28 days prior to randomization\n* Adequate hematological, renal, and hepatic function\n* Not pregnant or nursing\n* Fertile subjects must practice a medically approved method of contraception\n\nExclusion Criteria:\n\n* Prior history of other malignant tumors\n* Participation in another investigational study within 4 weeks prior to treatment start\n* Major surgery within 14 days prior to treatment start\n* Radiation treatment within 28 days prior to treatment start\n* Uncontrolled cardiac atrial or ventricular arrhythmias\n* Gastrointestinal tract disease such resulting in an inability to take oral medication\n* Known to be seropositive for HIV, HBV, or HCV\n* Uncontrolled cancer pain'}, 'identificationModule': {'nctId': 'NCT00550004', 'acronym': 'RP101', 'briefTitle': 'Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine', 'organization': {'class': 'INDUSTRY', 'fullName': 'SciClone Pharmaceuticals'}, 'officialTitle': 'Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma', 'orgStudyIdInfo': {'id': 'SCI-RP-Pan-P2-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'RP101 and Gemcitabine', 'interventionNames': ['Drug: RP101', 'Drug: Gemcitabine (1000 mg/m2)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'Placebo and Gemcitabine', 'interventionNames': ['Drug: Gemcitabine (1000 mg/m2)']}], 'interventions': [{'name': 'RP101', 'type': 'DRUG', 'description': '190 mg oral tablet', 'armGroupLabels': ['Arm 1']}, {'name': 'Gemcitabine (1000 mg/m2)', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': '30 minute intravenous infusion', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Medical Center, Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Tower Research Foundation at Tower Oncology', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University 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'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Northwest', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Bahía Blanca', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano Regional del Sur', 'geoPoint': {'lat': -38.7176, 'lon': -62.26545}}, {'city': 'Ciudad Autónoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Británico de Buenos Aires'}, {'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Zonal General de Agudos San Roque', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'city': 'Ijuí', 'country': 'Brazil', 'facility': 'Hospital de Caridade de Ijuí', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre, Serviço de Oncologia', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Nacional do Câncer', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Salvador', 'country': 'Brazil', 'facility': 'Núcleo de Oncologia da Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Câncer-AC Camargo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Fundación Arturo López Pérez', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Militar', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hôpital Gabriel Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Départemental', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Rennes', 'country': 'France', 'facility': "Centre Eugene Marquis, Service d'Oncologie Medicale", 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Dresden, Med. 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