Status:
UNKNOWN
A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
Lead Sponsor:
Fresenius Kabi Oncology Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
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 patient...
Eligibility Criteria
Inclusion
- Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent\* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
- Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)
- Patients must be of 18-65 years of age (inclusive of both)
- Patients with ECOG performance status between 0 - 2
- Patients with at least one measurable lesion as per RECIST
Exclusion
- 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.
- Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
- 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).
- Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00915369
Start Date
March 1 2009
End Date
April 1 2010
Last Update
February 8 2010
Active Locations (3)
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1
Nizam'S Institute of Medical Sciences
Hyderabaad, Andhra Pradesh, India
2
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India
3
SEAROC Cancer Center, S K Soni Hospital
Jaipur, Rajasthan, India