A study to compare two forms/formulations of Paclitaxel Injectable Suspension in metastatic Breast cancer patients
- Conditions
- Malignant neoplasm of breast,
- Registration Number
- CTRI/2020/09/028155
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Abioequivalence study with Paclitaxel injection in Metastatic breast cancerpatients with the following objective:
To investigatethe bioequivalence of Mylan’s Paclitaxel protein bound particles for injectablesuspension to Abraxane® following a single, intravenous injection of 260 mg/m2(1 × 100 mg) administered in breast cancer patients after failure ofcombination chemotherapy for metastatic disease or relapse within 6 months ofadjuvant chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 111
- 1.Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease or has had a relapse within 6months of adjuvant chemotherapy (Prior therapy should have included anthracycline unless clinically contraindicated) 2.Male and/or non-pregnant, non-lactating females aged 18 years or older but less than 70 years (both inclusive) 3.
- ECOG performance status of less or equal 2 4.Adequate hemopoietic, renal and liver function.
- 5.Patients receiving stable concomitant medications are allowed to participate 6.Treated and stable brain metastases.
- 1.Social Habits (for example) ingestion of alcoholic beverages, caffeine- or xanthine-containing food or beverage.
- 2.Use of any food (e.g. broccoli, Brussels sprouts, char-grilled meat, star fruit) known to induce or inhibit hepatic enzyme activity must be limited to no more than 2 standard servings.
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies except the disease/metastasis under study unless deemed not clinically significant by the Investigator 4.Patients who require a dose reduction to below 260 mg/m2.
- 5.Received chemotherapy and/ or radiotherapy within the past 30 days of first IMP administration or has not recovered from the side effects of previous therapy or has less than 5 washout periods from previous therapy.
- The toxicities should not be more than grade 1 at the time of dosing.
- 6.History of significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
- 7.Known, existing uncontrolled coagulopathy.
- 8.Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves (e.g. AUCL, AUCINF and Cmax) of unbound and total Paclitaxel Blood samples will be collected at various timepoints from day 1 to day 5 in both periods
- Secondary Outcome Measures
Name Time Method Not applicable Not applicable
Trial Locations
- Locations (17)
Meenakshi Mission Hospital &Research Centre
🇮🇳Madurai, TAMIL NADU, India
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
🇮🇳Amravati, MAHARASHTRA, India
Deenanath Mangeshkar Hospital & Research Centre
🇮🇳Pune, MAHARASHTRA, India
Dept of Surgery, GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Erode Cancer Hospital
🇮🇳Erode, TAMIL NADU, India
GBH Cancer Memorial Hospital
🇮🇳Udaipur, RAJASTHAN, India
HCG Manavata Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
HCG NCHRI Cancer Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Kailash Cancer Hospital and Research Center
🇮🇳Vadodara, GUJARAT, India
KLE Dr. Prabhakar Kore Hospital and MRC
🇮🇳Belgaum, KARNATAKA, India
Scroll for more (7 remaining)Meenakshi Mission Hospital &Research Centre🇮🇳Madurai, TAMIL NADU, IndiaDr Saju S VPrincipal investigator918891810070drsajusv@gmail.com