Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00907504
Status:
WITHDRAWN
Last Update Posted:
2014-06-17
First Post:
2009-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525021', 'term': 'figitumumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-16', 'studyFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Dec 2012'}], 'secondaryOutcomes': [{'measure': 'Progression Free survival', 'timeFrame': 'Dec 2011'}, {'measure': 'Objective Response', 'timeFrame': 'Dec 2011'}, {'measure': 'Overall Safety Profile', 'timeFrame': 'Dec 2012'}, {'measure': 'Patient Reported Outcome', 'timeFrame': 'Dec 2012'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Dec 2012'}, {'measure': 'Anti-drug Antibody', 'timeFrame': 'Dec 2012'}, {'measure': 'Biomarker Analysis', 'timeFrame': 'Dec 2012'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021017&StudyName=Study%20Of%20The%20Effect%20Of%20CP-751%2C871%20In%20Combination%20With%20Gemcitabine%20And%20Cisplatin%20In%20Patients%20With%20Advanced%20Non-Small%20Cell%20Lung%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive\n* Male or female \\> 18 years\n* Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Uncontrolled hypertension or diabetes;\n* Pregnant female;\n* Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.'}, 'identificationModule': {'nctId': 'NCT00907504', 'acronym': 'ADVIGO1017', 'briefTitle': 'Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'A4021017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CP-751,871 + Gemcitabine + Cisplatin', 'description': 'investigational arm', 'interventionNames': ['Drug: CP-751,871', 'Drug: Cisplatin', 'Drug: Gemcitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine + Cisplatin', 'description': 'standard of care', 'interventionNames': ['Drug: Cisplatin', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'CP-751,871', 'type': 'DRUG', 'description': 'CP-751,871 20mg/kg every 3 weeks', 'armGroupLabels': ['CP-751,871 + Gemcitabine + Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 80 mg/m2 every 3 weeks', 'armGroupLabels': ['CP-751,871 + Gemcitabine + Cisplatin']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle', 'armGroupLabels': ['CP-751,871 + Gemcitabine + Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 80 mg/m2 every 3 weeks', 'armGroupLabels': ['Gemcitabine + Cisplatin']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle', 'armGroupLabels': ['Gemcitabine + Cisplatin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}