Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT01107756
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2010-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Patients With Solid Tumours Receiving Granulocyte Colony Stimulating Factor as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Docetaxel Based Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078224', 'term': 'Lenograstim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-04', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-20', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.', 'timeFrame': 'For each granocyte 34 treatment, from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Incidence and severity of anaemia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Incidence and severity of asthenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Incidence and severity of anorexia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Incidence and severity of myalgia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Incidence and severity of nails changes, including nail disorders assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Incidence and severity of oral mucositis assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Neutropenia/febrile neutropenia associated days in hospital', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Neutropenia/febrile neutropenia associated use of anti-infectives', 'timeFrame': 'for each granocyte 34 treatment from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Incidence of chemotherapy dose reduction, withdrawals or treatment delays due to neutropenia or febrile neutropenia', 'timeFrame': 'from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Infection with (or without) neutropenia', 'timeFrame': 'from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}, {'measure': 'Relationship between the incidence and severity of neutropenia and the different chemotherapy regimens', 'timeFrame': 'from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasms (no Otherwise Specified)']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate the incidence and severity of neutropenia in patients being treated for solid tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary prophylaxis for chemotherapy-induced neutropenia.\n\nSecondary Objectives:\n\nHaematological : To evaluate the incidence and severity of febrile neutropenia (with or without antibiotics) and anaemia in patients being treated for solid tumors treated with a Taxotere based regimen when Granocyte is being used as a primary prophylaxis.\n\nNon-Haematological : To evaluate the incidence and severity of the following adverse events: asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours treated with a Taxotere based regimen; when Granocyte is being used as a primary prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients willing to sign informed consent prior to entry into the study,\n* Patients who have been prescribed a Taxotere based regimen,\n* Patients who have not yet started with the first Taxotere treatment,\n* Patients with a histological diagnosis of one of the following solid tumours: breast cancer, non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer, gastric cancer or head and neck cancer.\n\nExclusion criteria:\n\n* Patients who are enrolled in another clinical study,\n* Pregnant and/or breastfeeding patients, including women of childbearing potential not willing to use medically acceptable methods of contraception,\n* Patients with severe liver impairment,\n* Patients with severe renal function impairment,\n* Patients with a known hypersensitivity to Granocyte 34 or its constituents,\n* Patients with a history of severe hypersensitivity reactions to Taxotere or Polysorbate 80,\n* Patients with a baseline neutrophil count of \\< 1500cells/mm3,\n* Patients on other drugs that are contra-indications for the use with Taxotere,\n* Patients on con-current radiotherapy.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01107756', 'acronym': 'Grano-Tax', 'briefTitle': 'A Clinical Trial of Patients With Solid Tumours Receiving Granulocyte Colony Stimulating Factor as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Docetaxel Based Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase IV Clinical Trial of Patients With Solid Tumours Receiving Granocyte 34 (Granulocyte Colony Stimulating Factor (G-CSF)) as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Taxotere (Docetaxel) Based Regimen', 'orgStudyIdInfo': {'id': 'DOCET_L_04775'}, 'secondaryIdInfos': [{'id': 'U1111-1116-9574', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim)', 'description': 'Taxotere (Docetaxel) is given as background treatment and should be administered by the treating physician in accordance with the prescribing information outlined in the package insert + Granocyte 34 (lenograstim)', 'interventionNames': ['Drug: LENOGRASTIM (GRANOGYTE 34)']}], 'interventions': [{'name': 'LENOGRASTIM (GRANOGYTE 34)', 'type': 'DRUG', 'description': 'Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert', 'armGroupLabels': ['TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alberton', 'country': 'South Africa', 'facility': 'Investigational Site Number 53', 'geoPoint': {'lat': -26.26786, 'lon': 28.12225}}, {'city': 'Benoni', 'country': 'South Africa', 'facility': 'Investigational Site Number 55', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'zip': '9301', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Investigational Site Number 11', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '7460', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Investigational Site Number 21', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7500', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Investigational Site Number 27', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7800', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Investigational Site Number 26', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Investigational Site Number 22', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '4001', 'city': 'Durban', 'country': 'South Africa', 'facility': 'Investigational Site Number 13', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4091', 'city': 'Durban', 'country': 'South Africa', 'facility': 'Investigational Site Number 14', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'East London', 'country': 'South Africa', 'facility': 'Investigational Site Number 32', 'geoPoint': {'lat': -33.01529, 'lon': 27.91162}}, {'zip': '4126', 'city': 'eManzimtoti', 'country': 'South Africa', 'facility': 'Investigational Site Number 012', 'geoPoint': {'lat': -30.05219, 'lon': 30.88527}}, {'zip': '6530', 'city': 'George', 'country': 'South Africa', 'facility': 'Investigational Site Number 24', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'zip': '1709', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Investigational Site Number 51', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2000', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Investigational Site Number 12387', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2572', 'city': 'Klerksdorp', 'country': 'South Africa', 'facility': 'Investigational Site Number 47', 'geoPoint': {'lat': -26.85213, 'lon': 26.66672}}, {'zip': '1200', 'city': 'Mbombela', 'country': 'South Africa', 'facility': 'Investigational Site Number 43', 'geoPoint': {'lat': -25.47512, 'lon': 30.96935}}, {'zip': '0699', 'city': 'Polokwane', 'country': 'South Africa', 'facility': 'Investigational Site Number 44', 'geoPoint': {'lat': -23.90449, 'lon': 29.46885}}, {'zip': '6045', 'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Investigational Site Number 31', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '0084', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Investigational Site Number 42', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0102', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Investigational Site Number 41', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Investigational Site Number 451', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Rustenburg', 'country': 'South Africa', 'facility': 'Investigational Site Number 48', 'geoPoint': {'lat': -25.66756, 'lon': 27.24208}}, {'zip': '2193', 'city': 'Sandton', 'country': 'South Africa', 'facility': 'Investigational Site Number 54', 'geoPoint': {'lat': -26.104, 'lon': 28.054}}, {'city': 'Somerset West', 'country': 'South Africa', 'facility': 'Investigational Site Number 25', 'geoPoint': {'lat': -34.08401, 'lon': 18.82113}}, {'city': 'Vereeniging', 'country': 'South Africa', 'facility': 'Investigational Site Number 56', 'geoPoint': {'lat': -26.67313, 'lon': 27.92615}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}