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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Nanoxel (Nanoparticle Paclitaxel) at 4 different dose levels of 220, 260, 310 and 375 mg/m2. Each patient will recieve upto 6 cycles.
Nizam'S Institute of Medical Sciences
Hyderabaad, Andhra Pradesh, India
RECRUITINGKidwai Memorial Institute of Oncology
Bangalore, Karnataka, India
RECRUITINGSEAROC Cancer Center, S K Soni Hospital
Jaipur, Rajasthan, India
RECRUITINGThe 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
Time frame: Throughout the study
evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc.
Time frame: Throughout the study
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