Comparison of paclitaxel albumin-bound nanoparticles serum level with its original serum brand, Abraxane? in patients with metastatic breast cancer

Comparison of Paclinab serum level with its original serum brand, Abraxane in patients with metastatic breast cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130603013572N6

Enrollment

Registered

2021-02-01

Start date

2020-07-22

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

bioequivalence, pharmacokinetics.

Interventions

Intervention 1: Intervention group: Single dose administration of Paclinab® (paclitaxel protein-bound particles for injectable suspension) ( 260 mg/m2 as an IV infusion over 30 minutes) manufactured b

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy hemoglobin = 9 g/dl Female patients should be nonpregnant and non-lactating ANC = 1,500/mm3 platelet count = 100,000/mm3 serum creatinine ? 2 mg/dl serum bilirubin ? 1.5 mg/d Hepatic transaminases should be less than threefold of the upper limit of normal.

Exclusion criteria

Exclusion criteria: -Use of drugs or supplements known to influence the expression and function of CYP3A4 and/or CYP2C8 - Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug

Design outcomes

Primary

Measure	Time frame
Determination of drug concentration in blood plasma. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: High performance liquid chromatography.	—

Secondary

Measure	Time frame
Time to peak plasma concentration. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: observational.;Area under the plasma concentration–time curves. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: linear trapezoidal method.;Maximum plasma concentration. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: observational.	—

Measure

Time frame

Time to peak plasma concentration. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: observational.;Area under the plasma concentration–time curves. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: linear trapezoidal method.;Maximum plasma concentration. Timepoint: 0 min (pre-dose), 15 , 30 min (during infusion), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48 h after the end of infusion. Method of measurement: observational.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammadreza Rouini

Tehran University of Medical Sciences

rouini@tums.ac.ir+98 21 6695 9056

Outcome results

None listed

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