A clinical trial intended to compare safety and efficacy of two formulations of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in patients with metastatic breast cancer under fasting conditions.
- Conditions
- Health Condition 1: null- Metastatic Breast Cancer
- Registration Number
- CTRI/2016/08/007209
- Lead Sponsor
- PANACEA BIOTEC LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Female patients 18 to 70 years of age (both inclusive) having breast cancer who
a. Has histologically confirmed diagnosis of breast cancer.
b. Has metastatic breast cancer
c. Has failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
2.Body surface area (BSA) that is within 1.2 to 2.2 m2
3.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
4.Patient has adequate hematological, renal, and hepatic function.
1.Patients with a history of other malignancies
2.Patients who have previously received a taxane within the 30 days prior to randomization.
3.Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by CTCAE, with the exception of alopecia.
4.Prior chemotherapy must be completed at least 30 days prior to randomization (42 days for mitomycin C or nitrosoureas). Prior immunotherapy, prior antitumor hormonal therapy, and prior radiotherapy must be completed at least 14 days prior to randomization.
5.Patient had major surgery within 30 days prior to randomization, or patient has not recovered from prior major surgery.
6.Sensory / Peripheral neuropathy of Grade 2 or higher by CTCAE version 4.03 at Screening.
7.Abnormal ECG : QTc >470 msec in female patients at screening and randomization.
8.Patients with known brain metastases.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters: AUCt, AUCi, Kel, Cmax,Tmax,Kel, tHalf .Timepoint: Period 1 and 2: <br/ ><br>0.167, 0.333, 0.50, 0.833, 1.000, 1.500, 2.000, 3.000, 4.000, 5.000, 6.000, 8.000, 10.000, 16.000, 24.000, 48.000, 72.000, 96.000 and 120.000 hours after start of infusion <br/ ><br>
- Secondary Outcome Measures
Name Time Method ATimepoint: NA