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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.

A Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence, Single-Dose, Crossover, Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound) of Panacea Biotec, India with ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound) manufactured for Celgene Corporation, Summit, NJ in Patients with Metastatic Breast Cancer under Fasting Conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007209
Enrollment
90
Registered
2016-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Metastatic Breast Cancer

Interventions

Intervention1: Paclitaxel (Biosimilar) : Single intravenous infusion (260 mg/m2) over period of 30 minutes Control Intervention1: ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspensi

Sponsors

PANACEA BIOTEC LIMITED
Lead Sponsor
Cliantha Research Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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 4. Patient has adequate hematological, renal, and hepatic function.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters: AUCt, AUCi, Kel, Cmax,Tmax,Kel, tHalf .Timepoint: Period 1 and 2: 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—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactMr Vikrant Tripathi

Cliantha Research Limited

rgharia@cliantha.in9179-66219543

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026