CTRI/2020/09/028155 [Registered on: 30/09/2020] Trial Registered Prospectively
Last Modified On:
15/03/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study to compare two forms/formulations of Paclitaxel Injectable Suspension in metastatic Breast cancer patients
Scientific Title of Study
A randomized, multicenter, single dose, two-treatment, two-period, crossover, bioequivalence study of Mylan’s Paclitaxel protein bound particles for Injectable Suspension (albumin-bound) and Abraxis Bioscience’s Abraxane® for Injectable Suspension in 110 breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Jayashri Krishnan
Designation
Director – Operations
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
Tower 2, 1st Floor, South Wing, L & T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
Deputy General Manager Medical Monitoring and Safety
Affiliation
JSS Medical Research Asia Pacific Private Limited
Address
Tower 2, 1st Floor, South Wing, L & T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
Faridabad HARYANA 121003 India
Phone
09771407484
Fax
911296613520
Email
jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Mylan Laboratories Limited, India
Primary Sponsor
Name
Mylan Laboratories Limited
Address
9th Floor, Prestige Tech Park II,
VarthurHobli, Outer Ring Road,
Kadubesanahalli, Bengaluru-580087, India
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial
Dose- 260 mg/m2
Frequency: 3 weeks cycles (21 days) between two successive dosing periods.
Mode of Administration: IV
Intervention
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial
Mylan’s Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial
Dose- 260 mg/m2
Frequency: 3 weeks cycles (21 days) between two successive dosing periods.
Mode of Administration: IV
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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.
3. 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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
A
bioequivalence study with Paclitaxel injection in Metastatic breast cancer
patients with the following objective:
To investigate
the bioequivalence of Mylan’s Paclitaxel protein bound particles for injectable
suspension to Abraxane® following a single, intravenous injection of 260 mg/m2
(1 × 100 mg) administered in breast cancer patients after failure of
combination chemotherapy for metastatic disease or relapse within 6 months of
adjuvant chemotherapy.