A clinical study to assess the comparative blood concentration of two anti-cancer drugs (test and marketed Paclitaxel) in patients with breast cancer

Recruiting

• Registration Number: CTRI/2018/08/015506
• Lead Sponsor: Teva Pharmaceuticals USA

Brief Summary

The purpose of the proposed study is to assess the bioequivalence of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial manufactured by Teva Pharmachemie, The Netherlands, for Teva Pharmaceuticals USA and Abraxane® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albuminbound), 100 mg/vial manufactured by Abraxis BioScience LLC, USA for Celgene Corporation, USA in patients with metastatic breast cancer.

The objectives of this proposed trial are as below:

To demonstrate the bioequivalence between Test product (Albumin bound Paclitaxel) and Reference product (ABRAXANE®) in patients with Metastatic Breast Cancer.

To monitor safety

To determine other pharmacokinetic data



A total of 66 patients will be randomized in the study to establish bioequivalence



Analytical Method:

Unbound and total paclitaxel concentration in plasma will be measured using a validated bio-analytical method and according to the bio-analytical laboratory’s standard operating procedures and applicable regulatory

principles. Unbound paclitaxel concentration in plasma will be measured till 24 hours and total paclitaxel up to 72 hours after start of infusion.

Due to the sensitivity of Paclitaxel to ultraviolet (UV) light, the blood sample collection, sample transfer, sample separation, sample segregation and sample processing procedure will be done under yellow monochromatic light.

Sample collection, processing details and storage of plasma samples at study site will be provided in procedure manual for sample collection.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-15
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Female patient aged between 18 and 60 years of age (both inclusive).
• Patient with confirmed (histological or cytological) diagnosis of metastatic (NO known CNS metastasis) breast cancer or relapse within 6 months of adjuvant chemotherapy that included anthracycline unless clinically contraindicated.
• Life expectancy of more than 6 months as judged by the Investigator.
• ECOG PS (Eastern Cooperative Oncology Group performance status) of 0, 1 or 2.
• Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide,absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 30 days prior to study drug administration, during study and 30 days after the last dose of study drug.
• Patient able to understand, willing and likely to comply with study procedures and restrictions.
• Patient has provided signed and dated Informed consent before initiating any study-related procedures.

Exclusion Criteria

• History or presence of significant coexisting disease or surgery (within 4 weeks prior to start of therapy) that could affect the action or disposition of the investigational product, or clinical or laboratory assessments.
• Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease (any previous aforementioned treatments within 4 weeks of period 1 dosing).
• Patients with medical conditions that preclude administration of chemotherapy [uncontrolled inter-current illness like unstable angina, myocardial infarction (within 6 months prior to study entry), congestive heart failure, serious cardiac arrhythmias, uncontrolled diabetes, autoimmune disease, or any uncontrolled systemic disease (e.g. recurrent pleural effusion / ascites, active infections, patients with immune deficiency disorders) or patients already on immunosuppressive drugs] or any other significant co-morbid conditions as determined by the investigator(s).
• Clinical significant abnormal laboratory values.
• Bone marrow Function WBC greater than 3000/ microL Absolute Neutrophil Count less than 1500/ microL Platelet count less than 100,000/ microL Haemoglobin less than 9.0 g/dl Renal Function Serum Creatinine greater than 1.5 times ULN Hepatic Function AST greater than 2.5 times ULN ALT greater than 2.5 times ULN Alkaline Phosphatase greater than 2.5 times ULN Serum Albumin less than 3.0 gm/dL 5.
• Left ventricular ejection fraction (LVEF) of less than 50% as determined by Echocardiography (ECHO).
• History or presence of QTc prolongation (QTc greater than or equal to 470 ms, based on bazett’s correction method), left bundle branch block (LBBB), significant atrioventricular block (AV block) or any other significant cardiac disease.
• Current (within 2 weeks of period 1 dosing) or regular use of any medication (including over the counter [OTC], herbal or homeopathic preparations) that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessment.
• Positive result of urine screen for drugs of abuse (i.e., Amphetamines, Morphine, Benzodiazepines,Marijuana (THC), Cocaine and Barbiturates).
• Patients with positive HIV, HBV, HCV and/or VDRL.
• Known or suspected intolerance or hypersensitivity to Paclitaxel or any of the excipients or any other taxane.
• Patients who have participated in any other clinical study in the preceding 30 days prior to the start of the study.
• Patients who are pregnant or demonstrating a positive pregnancy screen or are currently breast-feeding or planning to become pregnant during study period.
• Patients who have taken medication that are either substrates or inhibitor/inducer of CYP3A4/CYP2C8 enzyme less than 4 weeks prior to start of IMP or require as concomitant medication.
• Patients with pre-existing sensory neuropathy of a severity greater than or equal to 3 grade as defined in National Cancer Institute Common Toxicity Criteria (CTC).

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the	PK Sampling- Day 1 to Day 4 of period-I & period-II of the study.
bioequivalence between Test	PK Sampling- Day 1 to Day 4 of period-I & period-II of the study.
product (Albumin bound	PK Sampling- Day 1 to Day 4 of period-I & period-II of the study.
Paclitaxel) and Reference	PK Sampling- Day 1 to Day 4 of period-I & period-II of the study.
product (ABRAXANE®) in	PK Sampling- Day 1 to Day 4 of period-I & period-II of the study.
patients with Metastatic	PK Sampling- Day 1 to Day 4 of period-I & period-II of the study.
Breast Cancer	PK Sampling- Day 1 to Day 4 of period-I & period-II of the study.

Secondary Outcome Measures

Name	Time	Method
To monitor safety.	To determine other

Trial Locations

Locations (20)

Apple Hospital; 🇮🇳 Surat, GUJARAT, India

Aster Adher Hospital (Prerarna Hospital); 🇮🇳 Kolhapur, MAHARASHTRA, India

Curie Manavata Cancer Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Department of Oncology, Meenakshi Mission Hospital & Research Centre; 🇮🇳 Madurai, TAMIL NADU, India

Erode Cancer Centre; 🇮🇳 Erode, TAMIL NADU, India

HCG City Cancer Centre; 🇮🇳 Krishna, ANDHRA PRADESH, India

Hindu Mission Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Kailash Cancer Hospital and Research CenterÂ; 🇮🇳 Vadodara, GUJARAT, India

KLES Dr.Prabhakra Kore Hospital& MRC; 🇮🇳 Belgaum, KARNATAKA, India

Kolhapur Cancer Pvt ltd; 🇮🇳 Kolhapur, MAHARASHTRA, India

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Apple Hospital

🇮🇳Surat, GUJARAT, India

Dr Jayanti Patel

Principal investigator

9825121347

pateldrjayanti@gmail.com