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CTRI Number  CTRI/2019/02/017445 [Registered on: 05/02/2019] Trial Registered Prospectively
Last Modified On: 04/06/2020
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 formulations of Paclitaxel Injectable Suspension in metastatic Breast cancer patients  
Scientific Title of Study   A randomized, open label, balanced, multicenter, two-treatment, two-period, two-sequence, two-way crossover, single dose, bioequivalence study with pharmacokinetic endpoints of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 of Ningbo Shouzheng Medicinal Research Co., Ltd. with ABRAXANE® for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 of Celgene Corporation, Summit, NJ 07901 in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy under fasting condition  
Trial Acronym  CO180006 
Secondary IDs if Any  
Secondary ID  Identifier 
CBCC/2018/004, Version 1.0, 01/Nov/2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmadabad GUJARAT India

Ahmadabad
GUJARAT
382210
India 
Phone  9726434204  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmadabad GUJARAT India


GUJARAT
382210
India 
Phone  9726434204  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmadabad GUJARAT India


GUJARAT
382210
India 
Phone  9726434204  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Ningbo Shouzheng Medicinal Research Co., Ltd. 
 
Primary Sponsor  
Name  Ningbo Shouzheng Medicinal Research Co Ltd 
Address  866 BinHai fourth Road, HangZhou Bay New Zone, NingBo City, Zhejiang Province, China 315336 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajnish Nagarkar  HCG Manavata Cancer Hospital and Research Centre  HCG Manavata Cancer Centre Clinical Research Department, First Floor, Behind Shivang Auto, Mumbai Naka,Nashik-422001
Nashik
MAHARASHTRA 		 919823061929

drraj@manavatacancercentre.com 
Dr Guruprasad Mohanty  Kailash Cancer Hospital and Research Centre  Kailash Cancer Hospital & Research Center, Clinical Research Department, First Floor, Muniseva Ashram, Goraj -391760,Vadodara
Vadodara
GUJARAT 		 919427432383

guru.prasad@greenashram.org 
Dr Minish Jain  Noble Hospital, Pvt, Limited  Noble Hospital, Pvt, Limited, Noble Annex building, Basement, Room No. 1 153, Magarpatta City Road, Hadapsar, Pune 411013
Pune
MAHARASHTRA 		 919823133390

minishjain009@gmail.com 
Dr Rakesh Neve  PDEA’s Ayurved Rugnalaya & Sterling Multi Speciality Hospital, Pune  PDEA’s Ayurved Rugnalaya & Sterling Multi Specialty Hospital, Research Department, Basement. Sector No. 27, Near Bhel Chowk, Nigdi Pradhikaran, Pimpri- Chinchwad, 411044, Maharashtra - 411044
Pune
MAHARASHTRA 		 919881143140

rakesh.neve23@gmail.com 
Dr Aniket Thoke  Sanjeevani CBCC Cancer Hospital  Sanjeevani CBCC USA Cancer Hospital Research Department Room No. 213 and 215 In front of Jain Mandir Dawada Colony Pachpedi Naka Raipur-492001 Chhattisgarh
Raipur
CHHATTISGARH 		 919752929741

drthoke@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Kailash Cancer and Medical Centre Institutional Ethics Committee  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Nobel Hospital Institutional Ethics Committee  Approved 
Sanjeevani Cancer Hospital Institutional Ethics Committee  Approved 
Sterling Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ABRAXANE® (Paclitaxel Albumin-Bound)  ABRAXANE® for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 as intravenous infusion over 30 minutes (±5 minutes) of Celgene Corporation, Summit, NJ 07901. 
Intervention  Paclitaxel (Albumin-Bound)  Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 as intravenous infusion over 30 minutes (±5 minutes) of Ningbo Shouzheng Medicinal Research Co., Ltd.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Willing and able to provide voluntary informed consent and to follow the protocol requirements.
2.Females aged 18 to 65 years (both inclusive) having Body Mass Index (BMI) at least 17.00 calculated as weight in kg/height in m2.
3. Patients with histopathologically /cytologically confirmed metastatic breast cancer
4. Patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or have had a relapse within 6 months of adjuvant chemotherapy. (Prior therapy should have included an anthracycline unless clinically contraindicated)
5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
6. Life expectancy of at least 6 months at the time of enrolment.
7. Acceptable hematology status:
a.Hemoglobin more than or equal to 9.0 g/dL
b.Absolute neutrophil count (ANC) more than or equal to 1500 cells/mm3
c.Platelet count more than or equal to 1,00,000 cells/mm3
8. Acceptable liver function:
a.Alanine aminotransferase (ALT) less than or equal to 2.5 X ULN
b.Aspartate aminotransferase (AST) less than or equal to 2.5 X ULN
c.Bilirubin more than or equal to 2 X ULN
d.Alkaline phosphatase ≤ 5 X ULN
9. Patients with Creatinine clearance ≥ 60 mL/minute
10. Patients with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0.
11. Patients who agree to use adequate contraception (eg, hormonal, chemical, double-barrier, or abstinence) while in the study and for 3 months after study participation is discontinued.
12. No history of addiction to any recreational drug or drug dependence or alcohol addiction. 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Paclitaxel or the components of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) or to any of the related drugs (other taxane products).
2.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
3.Patients taking any of the inhibitors or inducers of either CYP2C8 or CYP3A4.
4.Known CNS metastasis.
5.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
6.Surgical or other non-healing wounds.
7.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
8.Patients with current clinical or laboratory evidence of active infection.
9.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
10.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
11.Participation in any clinical study within 90 days before the first dose of Investigational Product.
12.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of investigational product for the current study.
13.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
14.Breastfeeding. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the BE by comparing PK parameters of Paclitaxel Protein-Bound Particles for Injectable Suspension 100mg/vial with ABRAXANE® for Injectable Suspension 100mg/vial in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy under fasting condition; To assess variability, optimize sample collection time intervals and provide the information for determination of sample size.  The pre-infusion blood sample (00.00) will be drawn within one hour prior to the start of infusion and at 0.08 (5 min), 0.17 (10 min), 0.25 (15 min), 0.33 (20 min), 0.42 (25 min), 0.50 (30 min), 0.58 (35 min), 0.67 (40 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00 and 120.00 hours after the start of infusion in each period. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to assess the safety and tolerability in patients  As per Study Requirement 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2019 
Date of Study Completion (India) 18/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a randomized, open label, balanced, multicenter, two-treatment, two-period, two-sequence, two-way crossover, single dose, bioequivalence study with pharmacokinetic endpoints of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) 100 mg/vial in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy under fasting condition.

The primary objective of study is to assess the bioequivalence by comparing PK parameters and to assess variability, optimize sample collection time intervals and provide the information for determination of sample size of Pivotal BE study. Upon randomization, patients will receive assigned study drug on Day 1 (Period 01) and Day 22 (Period 02) based on the randomization schedule (either Test (A) or Reference (B)) at a dose of 260mg/m2 intravenously over 30 minutes under fasting conditions. Statistical analysis will be performed on the pharmacokinetic parameters using SAS® statistical software. The 90% confidence interval of the relative mean (Geometric mean) of the test to reference formulation for Ln-transformed Cmax, AUC0-t and AUC0-inf should be within 80.00% to 125.00% for unbound and total paclitaxel to establish bioequivalence.

 
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