Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00915369
Status:
UNKNOWN
Last Update Posted:
2010-02-08
First Post:
2009-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-05', 'studyFirstSubmitDate': '2009-06-03', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcomes of the study would be the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2); Ability to identify a dose higher than 220 mg/m2 that demonstrate better efficacy and manageable toxicity', 'timeFrame': 'Throughout the study'}], 'secondaryOutcomes': [{'measure': 'evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc.', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a multicentre, open label, non-randomized phase I study. The main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent\\* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.\n* Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)\n* Patients must be of 18-65 years of age (inclusive of both)\n* Patients with ECOG performance status between 0 - 2\n* Patients with at least one measurable lesion as per RECIST\n\nExclusion Criteria:\n\n* Patients with ER/PR positive status. Patients who demonstrate HER2 over expression will be excluded. Alternatively, the patients enrolled should have previously received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+ or with FISH/CIS.\n* Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.\n* Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (Patients requiring local radiotherapy for non- target bone lesion will be included).\n* Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).'}, 'identificationModule': {'nctId': 'NCT00915369', 'briefTitle': 'A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi Oncology Ltd.'}, 'officialTitle': 'A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'DO/NDR/02/2008/01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nanoxel (Paclitaxel Nanoparticle formulation )', 'type': 'DRUG', 'description': 'Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375 mg/m2. Each patient will recieve upto 6 cycles.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hyderabaad', 'state': 'Andhra Pradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'D. Raghunadharao, DM', 'role': 'CONTACT', 'email': 'draghu_hyd@dataone.in', 'phone': '+91.40.23372947'}, {'name': 'D Raghunadharao, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nizam'S Institute of Medical Sciences"}, {'city': 'Bangalore', 'state': 'Karnataka', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Govind Babu', 'role': 'CONTACT', 'email': 'kgbtrials@yahoo.co.in', 'phone': '+91.80.26579503'}, {'name': 'Govind Babu, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kidwai Memorial Institute of Oncology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Jaipur', 'state': 'Rajasthan', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Anish Maru, DM', 'role': 'CONTACT', 'email': 'anishmaru@yahoo.com', 'phone': '+91-0141-2232409-11', 'phoneExt': '106'}, {'name': 'Anish Maru, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SEAROC Cancer Center, S K Soni Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'centralContacts': [{'name': 'Shivakant Mishra, PhD', 'role': 'CONTACT', 'email': 'shivakant.mishra@fresenius-kabi.com', 'phone': '+91.120.4378604'}, {'name': 'Amit Sharma, MD', 'role': 'CONTACT', 'email': 'amit_delhi.sharma@fresenius-kabi.com', 'phone': '+91.120.4378415'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi Oncology Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. S. K. Mishra, Vice President - Clinical Research & Medical Services', 'oldOrganization': 'Fresenius Kabi Oncology Ltd.'}}}}