The study is planned to compare Cipla product- Paclitaxel with Innovator product Celgene Corporation product - ABRAXANE® to
establish that both are equally effective in treating metastatic breast cancer patients.
A multicenter, open label, randomized, balanced, two treatment, two-sequence, four period, replicate crossover, single dose, bioequivalence study of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation, USA in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy
Clinical Research Department, Clinical Research Division, Room No 101, Hyderabad 6-1-1040/1 to 4, Lakdi ka pool, Hyderabad 500004, Telangana Hyderabad TELANGANA
9849032198
drcsairam@gmail.com
Dr Sanketh Kotne
HCG Cancer Centre
Clinical Research Department, Clinical Research Division, Room No 219, Plot No 10, Survey No 13P, APIIC Health City, Chinagadili, Arilova, Visakhapatnam-530040, Andhra Pradesh. Visakhapatnam ANDHRA PRADESH
7013222831
drsanketh.k@hcgel.com
Dr K Lakshmi Priyadarshini
HCG City Cancer Centre
HCG City Cancer Centre, 33-25-33, CH Venkata Krishnayya Street, Suryarao Pet, Vijayawada-520002 Krishna ANDHRA PRADESH
9502945399 866243071 priyadarshini006@gmail.com
Dr Rajnish Nagarkar
HCG Manavata Cancer Centre
HCG Manavata Cancer Centre,
Clinical Research Department, Clinical Research Division, First Floor, Behind Shivang Auto Mumbai Naka Nashik-422002 Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr Niraj Bhatt
Kailash Cancer Hospital & Research Centre
Clinical Research Department, Clinical Research Division, Room No 101, Muni Seva Ashram, Goraj, Waghodia, Vadodara, Gujarat 391760 Vadodara GUJARAT
9925581480
niraj.bhatt@greenashram.org
Dr Saurabh Prasad
Kingsway Hospital
Clinical Research Department, Clinical Research Division, Room No 101, 44 Kingsway Road, Nagpur 440001, Maharashtra Nagpur MAHARASHTRA
7066580511
drsaurabhprasad@gmail.com
Dr Shanti Prakash Shrivastav
Kiran Hospital Multi Super Speciality Hospital & Research Center
Clinical Research Department, Clinical Research Division, Room No 201, Near Sumul Dairy, Surat 395004 Surat GUJARAT
8826734321
sp.shrivastav@kiranhospital.com
Dr Nilesh Dhamne
Kolhapur cancer centre Pvt Ltd
Clinical Research Department, Clinical Research Division, Room No 02, R.S.238 Opp Mayur Petrol pump, Gokul shirgaon, Kolhapur, Mahrashtra-416234 Kolhapur MAHARASHTRA
7738245698
dr.nilesh.gmc@gmail.com
Dr K S Sethna
LTMMC & LTMGH Hospital
LTMMC & LTMGH Hospital,
Clinical Research Department, Clinical Research Division, Second Floor, B R Ambedkar Road, Sion, Mumbai - 400022 Mumbai MAHARASHTRA
9820882603
kssethna@yahoo.co.uk
Dr Murali Subramanian
Medstar speciality Hospital
Clinical Research Department, Clinical Research Division, Room No 1, #641/17/1/3, Kodigehalli main road, Sahakar nagar post, Bangalore 560092 Bangalore KARNATAKA
9945813327
medstarclinicalresearch@gmail.com
Dr Prakash S S
Mysore Medical College And Research Institute
Clinical Research Department, Clinical Research Division, Room No 4, Ground Floor, Irwin Road, next to Railway Staion, Mysore, Karnataka 570001 Mysore KARNATAKA
9901000559
Prakashyesyes@yahoo.com
Dr Smitha C Saladanha
Nano Hospitals
Nano Hospitals #79 Sir M Visveswaraya Road, Near Arekere Sai Baba Temple, Off Banaraghatta Road- Bengaluru-560076 Bangalore KARNATAKA
9844685166
saldanhasmitha@gmail.com
Dr Jayanti Patel
Nirmal Hospital
Clinical Research Department, Clinical Research Division, Room No 501, Ring Road, Surat, Gujarat 395002 Surat GUJARAT
9979530073
pateldrjayanti@gmail.com
Dr Minish Jain
Noble Hospital Pvt Ltd
Clinical Research
Department, Clinical Research Division, Room No 124, Basement,
Noble Annex Building
153 A Magarpatta City road Hadapsar Pune 411013 Pune MAHARASHTRA
P.D.E.As Ayurved Rugnalaya and Sterling Multispeciality Hospital
Clinical Research Department, Clinical Research Division, Rooom No 109,
Sec. No 27 Near Bhel
Chowk Nigdi
Pradhikaran Pune
411044 Pune MAHARASHTRA
9881143140 02025651602 Rakesh.neve@gmail.com
Dr Ashwin Rajbhoj
Pulse Multispeciality Hospital
Clinical Research Department, Clinical Research Division, Room No. 001, Survey No 51/7/B/1, Vishwa Arcade Bombay Bangalore Highway, Narhe, Pune -411041, Maharashtra Pune MAHARASHTRA
8793398680
ash127win@gmail.com
Dr Rajendersingh Arora
Sujan Surgical Cancer Hospital
Clinical Research Department, Clinical Research Division, Basement, Amravati 52/B, Main Road, Shankar Nagar, Gopal Nagar, Amravati, Maharashtra 444605 Amravati MAHARASHTRA
9823097573
rsaroradr@gmail.com
Dr Ankit Patel
Sunshine Global Hospital
Sunshine Global Hospital,
Clinical Research Department, Clinical Research Division, First Floor, Beside Big Bazar,Gaurav Path Dumas Road-Surat-395007 Surat GUJARAT
1.Female patients, 18 to 65 years of age (both inclusive) at the time of screening and capable of giving written informed consent prior to receiving any study medication.
2. Meets one of the following criteria:
i. Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease
ii. Has had a relapse within 6 months of adjuvant chemotherapy
iii. Has histological or cytological confirmed breast cancer who is a candidate for albumin bound paclitaxel therapy in accordance with the standard of care (NCCN guidelines- Breast Cancer) as per PI judgement.
Note: In the case of items i and ii above, prior therapy should have included an anthracycline, such as doxorubicin, daunorubicin, mitoxantrone or other related compounds unless clinically contraindicated.
3.Patients with life expectancy of at least 6 months as per the investigator’s opinion.
4.ECOG performance status of less than equal to 2.
5.Acceptable hemopoeitic, renal and liver function.
Bone marrow function:
ANC Greater than equal to 1500cells/mm3 or 1500cells/microlitre, Platelet count Greater than equal to 100,000/mm3, Hemoglobin Greater than equal to 9.0 g/dl
Renal function: Serum Creatinine less than 1.5 times ULN,
Hepatic function: AST and ALT less than equal to 2.5 times ULN (less than equal to 4 X ULN for liver metastasis)
Alkaline phosphatase less than 2 times ULN (less than equal to 5 X ULN for bone metastasis)
Bilirubin less than equal to 1.5 times ULN
6.All other clinical laboratory values deemed as not clinically significant by the principal investigator/sub-investigator.
7.Availability for the entire study duration and willingness to adhere to the protocol requirements.
8.Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test (UPT) at baseline, must be using an adequate method of contraception and must be willing to avoid getting pregnant during the study period.
Female patients must fulfill at least one of the following:
8.1 Be surgically sterile for a minimum of 6 months of study consent date;
8.2 Post-menopausal for a minimum of 1 year of study consent date;
8.3 Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to dosing and until 6 months after the study has ended (last study procedure).
8.4 Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence alone can be used as a method of contraception.
ExclusionCriteria
Details
1. History of allergy or hypersensitivity reactions to a paclitaxel or the components of paclitaxel protein-bound particles for injectable suspension (albumin bound) or any related compound at any dose.
2. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (e.g., intra-abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina pectoris), cerebrovascular, pulmonary (e.g., interstitial lung disease Pneumonitis), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological (e.g., bleeding diathesis or coagulopathy) disease or condition other than cancer unless determined as not clinically significant by the investigator.
3.History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
4.Sensory peripheral neuropathy of Greater than Grade 2 at baseline.
5.Presence of any significant physical or organ abnormality or active opportunistic infection (i.e. mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis jiroveci) as determined by the Investigator.
6.Patients not completely recovered from any toxicities from previous chemo-, hormone-, immuno-, or radiotherapies less than equal to Grade 1.
7.A positive HIV, Hepatitis B surface antigen, Hepatitis C, COVID-19 (COVID-19 testing will be handled as per government driven protocol if applicable), drugs of abuse or urine alcohol test.
8.Difficulty in fasting or consuming Non-high fat meals.
9.Patients who are:
9.1 pregnant
9.2 breast feeding
9.3 of childbearing potential without a negative pregnancy test at baseline
9.4 had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
10.Known history or presence of:
10.1 Alcohol abuse or dependence within one year prior to first drug administration;
10.2 Drug abuse or dependence;
10.3 Severe allergic reactions (e.g. anaphylactic reactions, angioedema)
11.History of difficulty with donating blood or difficulty in accessibility of veins.
12.Any clinically significant abnormal findings in 12 lead ECG, 2D ECHO, X-ray findings, as judged by investigator.
13.Patient is taking inhibitor, or inducer of CYP2C8 or CYP3A4 enzymes and in whom these drugs are unable to be restricted for the entire study period. (Annexure IV)
14.Any other condition, that in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
15.Participation in any clinical study, chemotherapy and/ or radiotherapy within the past 30 days of first IP administration or has less than 5 half-lives from previous therapy whichever is longer.
16.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To compare and evaluate the single dose bioavailability of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation, USA
96 hours
Secondary Outcome
Outcome
TimePoints
To monitor the adverse events and to ensure the safety of patients
96 hours
Target Sample Size
Total Sample Size="32" Sample Size from India="32" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is being conducted to establish bioequivalence between Cipla product and the comparator product in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.