CTRI/2016/08/007209 [Registered on: 19/08/2016] Trial Registered Prospectively
Last Modified On:
29/01/2020
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A clinical trial intended to compare safety and efficacy of two formulations of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in patients with metastatic breast cancer under fasting conditions.
Scientific Title of Study
A Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence, Single-Dose, Crossover, Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound) of Panacea Biotec, India with ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound) manufactured for Celgene Corporation, Summit, NJ in Patients with Metastatic Breast Cancer under Fasting Conditions.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CRL121526, version 2.0 dated 18 Feb 2016
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Ripal Gharia
Designation
Sr. Medical Monitor
Affiliation
Cliantha Research Limited
Address
Garden View Corporate House No.8,3rd Floor
Opposite Auda Garden,
Bodakdev,
Ahmedabad
India
4th Floor, Clnical research dept, Udhna Darwaja, Ring Road, Surat 395002, Gujarat, India Surat GUJARAT
91-9376913131 91261-6696078 gnonco@gmail.com
Dr Rashmi Gudur
Apple Saraswati Multispeciality Hospital
Apple Saraswati Multispeciality Hospital, A Venture of Apple Hospital and Research Institute Ltd, Circuit House Kadamwadi Road, Kolhapur Maharashtra Kolhapur MAHARASHTRA
9860249027
kanvikar.rashmi@gmail.com
DrFrancisco M Oswald L Desa
Campal clinic
Campal clinic opp,parade grounds campal,panaji North Goa GOA
9158592127 0832-6644404 cromgoa@gmail.com
Dr Rajnish Nagarkar
Curie Manavata Cancer Centre
OPD, Ground Floor, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik-422004, Maharashtra, India Nashik MAHARASHTRA
Deaprtment of Radiation Oncology, Ground Floor, Lake area, Melur Road, Madurai- 625017, Tamilnadu, India Madurai TAMIL NADU
91-9787713004 91452-2586353 drkskk@yahoo.com
Dr Rakesh Neve
Nobel hospital Pvt Ltd
153, Magarpatta City Road, Hadapsar, Pune, Maharashtra 411013 Pune MAHARASHTRA
91-9881143140
rakesh.neve@gmail.com
DrAniket Thoke
Sanjeevani CBCC USA Cancer Hospital
Sanjeevani CBCC USA Cancer Hospital,
Infront of Jain Mandir,
Dawada Colony, Pachpedi Naka,
Raipur-492001(C.G)
India Raipur CHHATTISGARH
9752929741 91-771-4013120 drthoke@gmail.com
Dr Lokanatha Dasappa
Sri Venkateshwara Hospital
Sri Venkateshwara Hospital, #86 Hosur Main Road, Madiwala, Bangalore - 56006, Karnataka Bangalore KARNATAKA
9845695589
drlok61@gmail.com
Dr KCLakshmaiah
Srinivasam Cancer Care Hospital India Pvt.Ltd
Srinivasam Cancer Care Hospital India Pvt.Ltd.,
#236/1, Vijayashree layout,
Arekere, Bannerghatta Main Road,
Banglore-560076,
Karnataka Bangalore KARNATAKA
Institutional Ethics Committee,Dept. Of Pharmacology, Govt. Medical College and Hospital, Nagpur-440003, Maharashtra
Approved
IPGME & R Research Oversight Committee, 244,AJC Bose Road,Kolkata-700020
Approved
Kailash Cancer & Medical Centre Institutional Ethics Committee,Department of Clinical Research,Kailash Cancer Hospital and Research Centre, Muni Seva Ashram, P.O. Goraj-391760, Tal.Waghodia, Dis.Vadodara, Gujarat, India
Approved
Kolhapur Cancer Centere Institutional Ethics Committee Opposite Mayur Petrol Pump,Gokul Shirgaon, Karveer, Kolhapur, Maharashtra-416234
Approved
LPR Ethics Committee Lifepoint Multispeciality Hospital , 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune- 411057, Maharashtra, India
Approved
Manavata Clinical Research Institutional Ethics Committee (MCRI EC) , Curie Manavata Cancer Centre, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik-422004, Maharashtra, India
Approved
Manipal University Ethics Committee, 7th Floor, KMC Hospital, Attavar, Mangalore- 575001, Karnataka, India
Approved
Sri Venkateshwara Hospital Ethics Committee, Sri Venkateshwara Hospital, #86 Hosur Main Road, Madiwala, Bangalore - 56006, Karnataka
Approved
Srinivasam Cancer Care Hospital - Institutional Ethics Committee, Board Room,4 th Floor, Srinivasam Cancer Care Hospital India Pvt. Ltd., #236/1, Vijayashree layout, Arekere, Bannerghatta main Road, Banglore-560076, Karnataka
Approved
Sterling Hospital Institutional Ethics Committee, Sec No 27, Near Bhel Chowk, Nigdi Pradhikaran, Pune 411044, Maharashtra, India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Metastatic Breast Cancer,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound)
Single intravenous infusion (260 mg/m2) over period of 30 minutes
Intervention
Paclitaxel
(Biosimilar)
Single intravenous infusion (260 mg/m2) over period of 30 minutes
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Female
Details
1. Female patients 18 to 70 years of age (both inclusive) having breast cancer who
a. Has histologically confirmed diagnosis of breast cancer.
b. Has metastatic breast cancer
c. Has failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
2. Body surface area (BSA) that is within 1.2 to 2.2 m2
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
4. Patient has adequate hematological, renal, and hepatic function.
ExclusionCriteria
Details
1. Patients with a history of other malignancies
2. Patients who have previously received a taxane within the 30 days prior to randomization.
3. Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by CTCAE, with the exception of alopecia.
4. Prior chemotherapy must be completed at least 30 days prior to randomization (42 days for mitomycin C or nitrosoureas). Prior immunotherapy, prior antitumor hormonal therapy, and prior radiotherapy must be completed at least 14 days prior to randomization.
5. Patient had major surgery within 30 days prior to randomization, or patient has not recovered from prior major surgery.
6. Sensory / Peripheral neuropathy of Grade 2 or higher by CTCAE version 4.03 at Screening.
7. Abnormal ECG : QTc>470 msec in female patients at screening and randomization.
8. Patients with known brain metastases.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is to evaluate the bioequivalence of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound) of Panacea Biotec Ltd, India with ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound) of manufactured for Celgene Corporation, Summit, NJ in patients with Metastatic Breast Cancer under fasting conditions. Expected study duration of clinical part is at least 26 days from the day of check-in of first period. Two consecutive treatment cycles will be used for the two treatment periods. The two arms of the crossover study will be conducted on two of the days when the patients are scheduled to receive their usual therapy so that the treatment regimen is not altered or delayed. Pharmacokinetic parameters Cmax, AUCt, AUCi, Tmax, Kel and tHalf will be calculated using professional software.