Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT00707304
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2008-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C515276', 'term': 'talactoferrin alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 742}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'dispFirstSubmitDate': '2012-08-13', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-13', 'studyFirstSubmitDate': '2008-06-26', 'dispFirstSubmitQcDate': '2012-08-13', 'studyFirstSubmitQcDate': '2008-06-26', 'dispFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'After the occurence of the required number of events'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'At time of final analysis'}, {'measure': 'Objective response and disease stablization rate', 'timeFrame': 'At time of final analysis'}, {'measure': 'Safety and tolerability', 'timeFrame': 'At time of final analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer', 'Talactoferrin', 'Dendritic Cell Recruiter and Activator', 'Immunomodulatory agent'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIB or IV NSCLC\n* Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC\n* At least one target lesion that is unirradiated and measurable by RECIST\n* Adequate hematologic, renal and hepatic function\n* ECOG 0, 1, or 2\n* Able to understand and sign an Informed Consent\n\nExclusion Criteria:\n\n* Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization\n* Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications\n* History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years\n* Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure\n* Serious active infection\n* Psychiatric illness/ social situations that would limit study compliance\n* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol\n* Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)\n* Known HIV positive or on active anti-retroviral therapy\n* Known Hepatitis B surface antigen positive or hepatitis C positive\n* Receipt of any investigational medication within 4 weeks prior to randomization\n* Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment\n* Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment\n* Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian"}, 'identificationModule': {'nctId': 'NCT00707304', 'acronym': 'FORTIS-M', 'briefTitle': 'Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer', 'nctIdAliases': ['NCT00937209'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Agennix'}, 'officialTitle': 'FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens', 'orgStudyIdInfo': {'id': 'LF-0207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Talactoferrin alfa (talactoferrin or TLF, also known as recombinant human lactoferrin, rhLF or talactoferrinum alfa) is a recombinant version of the glycoprotein expressed in and purified from Aspergillus niger var. awamori. Talactoferrin is structurally and functionally similar to native human lactoferrin. The structural equivalence of talactoferrin to native human lactoferrin has been demonstrated by a comparison of the 3-dimensional structure, molecular weight, biological activity and other physicochemical properties, and is known to differ only in the nature of glycosylation.', 'interventionNames': ['Drug: Talactoferrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo contains the same phosphate-based buffer used as the diluent for the talactoferrin solution. In addition, the placebo will contain FD\\&C/EU grade dyes suitable for oral use to mimic the color of the vialed drug product.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Talactoferrin', 'type': 'DRUG', 'otherNames': ['talactoferrin alfa', 'TLF', 'recombinant human lactoferrin', 'rhLF'], 'description': 'Oral, 1.5 grams twice per day', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral, twice per day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85122', 'city': 'Casa Grande', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Oasis Cancer Center', 'geoPoint': {'lat': 32.8795, 'lon': -111.75735}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Pasco Pinellas Cancer Center', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Care Specialists of Central Illinois', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Care & Hematology Specialists of Chicagoland', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, 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