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CTRI Number  CTRI/2024/03/064383 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Bioequivalence (BE) study of Paclitaxel 100mg/vial with ABRAXANE® 100mg/vial in subject with metastatic Breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. 
Scientific Title of Study   An open label, multi-center, randomized, two-treatment, two period, two-sequence, two-way cross-over, single dose, Bioequivalence (BE) study with pharmacokinetic (PK) endpoints of Paclitaxel 100mg/vial injectable suspension at a dose of 260 mg/m2 of Anbison Lab, China with ABRAXANE® 100mg/vial for Injectable suspension at a dose of 260 mg/m2 of Celgene Corporation Summit, NJ 07901 in subject with metastatic Breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MW230015, Version No. 1.0 dated 25-OCT-2023  Protocol Number 
Version No. 2.0 dated 28-Dec-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  TURQUOISE-4, 6th Floor, Sardar Patel Ring Rd, opp. Apple Wood, Ahmedabad, Gujarat 382210, India
S.G. Highway, Sarkhej
Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  TURQUOISE-4, 6th Floor, Sardar Patel Ring Rd, opp. Apple Wood, Ahmedabad, Gujarat 382210, India
S.G. Highway, Sarkhej
Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  TURQUOISE-4, 6th Floor, Sardar Patel Ring Rd, opp. Apple Wood, Ahmedabad, Gujarat 382210, India
S.G. Highway, Sarkhej
Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Anbison Lab. Co., Ltd. No.18 Qujing Road, Xuhui District, Shanghai, P.R. China  
 
Primary Sponsor  
Name  Anbison Lab. Co., Ltd. 
Address  No.18 Qujing Road, Xuhui District, Shanghai, P.R. China 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Ghanekar  Ashirwad Hospital and Research Centre  Maratha Section, next to Jijamata Udyan, Ulhasnagar - 421004, Maharashtra, India
Thane
MAHARASHTRA 		 9920018399

ghanekarayg2023@gmail.com 
Dr Minish Jain  CIMET’s Inamdar Multispeciality Hospital  S.N.-15, Vitthal Rao Shivarkar Rd, Fatima Nagar, Wanowrie, Pune - 411040, Maharashtra, India
Pune
MAHARASHTRA 		 9823133390

minishjain009@gmail.com 
Dr K Velavan  Erode Cancer Center Pvt. Ltd.  1/393 Velavan Nagar, Perundurai Road, Thindal, Erode - 638012, Tamilnadu, India
Erode
TAMIL NADU 		 9842334222

kvels@rediffmail.com 
Dr Govindaraj Ganesan  Harshamitra Super Speciality Cancer Centre and Research Institute  101/4A, Mathur Panchayat Road, Trichy - Madurai Highway, Nagamangalam - 620012, Tamil Nadu, India
Madurai
TAMIL NADU 		 7373542777

govindarajganesan@gmail.com 
Dr Raj Nagarkar  HCG Manavata Cancer Centre  Behind Shivang Auto, Mumbai Naka, Nashik - 422002, Maharashtra, India
Nashik
MAHARASHTRA 		 9823061929

drraj@manavatacancercentre.com 
Dr Asma Pathan  Indrayani Hospital and Cancer Institute  Alandi - Chakan Road, Alandi, Devachi, Tal. Khed, Pune - 412105 , Maharashtra, India
Pune
MAHARASHTRA 		 8007167716

asmapathan124@gmail.com 
Dr Sahil Gupta  Kailash Cancer Hospital and Research Centre  Muni Seva Ashram Goraj, Waghodia - 391760, Vadodara, Gujarat, India
Vadodara
GUJARAT 		 9473662132

sahil.gupta@greenashram.org 
Dr K Kishore Kumar  Mahatma Gandhi Cancer Hospital and Research Institute  Plot No:1, Sector:7, MVP Colony, Visakhapatnam - 530017, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 9985610862

kishorekumarmedico@gmail.com 
Dr Anil Kumar MR  Oncoville Cancer Hospital and Research Centre  No 4, 80 ft. road, Marilingappa Extension, Naagarabhaavi, Bengaluru-560072, Karnataka, India
Bangalore
KARNATAKA 		 9739808507

dranil.onco@gmail.com 
Dr Yamini Patel  Sir Sayajirao General Hospital  Jail Road, Vadodara - 390001, Gujarat, India
Vadodara
GUJARAT 		 9426367470

dryamini_patel@yahoo.com 
Dr Ghanashyam Biswas  Sparsh Hospital and Critical Care Pvt Ltd.  Plot no. A/407, Saheed Nagar, Bhubaneswar-751007, Odisha, India
Cuttack
ORISSA 		 9937500878

drgbiswas@gmail.com 
Dr Neha Gupta  Swami Harshankaranand Ji Hospital and Research Centre  N 8/237, Newada B.H.U- BLW Road, Sundarpur, Varanasi - 221005, Uttar Pradesh, India
Varanasi
UTTAR PRADESH 		 7839510942

drneha_500@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ashirwad Ethics Committee  Approved 
CIMETs Inamdar Multispeciality Hospital  Approved 
Independent Ethics Committee Integrated Namaste Services  Approved 
Institutional Ethics Committee ERODE Cancer Centre  Approved 
Institutional Ethics Committee for Human Research  Approved 
Institutional Ethics Committee Harshamitra Superspeciality Cancer Centre  Approved 
Institutional Ethics Committee Kailash Cancer Hospital & Research Centre  Approved 
Institutional Ethics Committee Oncoville Cancer Hospital and Research Center  Approved 
Institutional Ethics Committee Sparsh Hospitals and Critical Care Private Limited  Approved 
Institutional Review Board Mahatma Gandhi Cancer Hospital & Research Institute  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Narsimha Saraswati Medical Foundation Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C798||Secondary malignant neoplasm of other specified sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ABRAXANE® 100mg/vial for Injectable suspension at a dose of 260 mg/m2 of Celgene Corporation Summit.  Dose: 100mg/vial for Injectable suspension at a dose of 260 mg/m2 Duration of Therapy:28 Days Route of Administration: Intravenous  
Intervention  Paclitaxel 100mg/vial injectable suspension at a dose of 260 mg/m2 manufactured by Jiangsu Anbison Pharma, China  Dose: 100mg/vial injectable suspension at a dose of 260 mg/m2, Duration of Therapy: 28 Days, Route of Administration: Intravenous  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Willing and able to provide written informed consent prior to any study-related activities being performed and to follow protocol requirements
2. Female subjects aged 18 to 65 years (both inclusive) and having Body Mass Index at least 17 kg per m2.
3. Subjects with histopathologically or cytologically confirmed breast cancer
4. Subjects with breast cancer after failure of combination chemotherapy for metastatic disease or having relapse within 6 months of adjuvant chemotherapy. (Prior therapy should have included an anthracycline unless clinically contraindicated).
5. Life expectancy of greater than 90 days at the time of enrolment.
6. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to2
7. Acceptable hematology status
a. Hemoglobin greater than or equal to 9 g per dL
b. Absolute neutrophil count (ANC) greater than or equal to 1500 cells per micro L
c. Platelet count greater than or equal to 1, 00,000 cells per mm3
8. Acceptable liver function:
a. Alanine aminotransferase (ALT) less than or equal to2.5 X upper limit of normal (ULN)
b. Aspartate aminotransferase (AST) less than or equal to2.5 X ULN
c. Bilirubin less than or equal to1.5 X ULN
d. Alkaline phosphatase less than or equal to2.5 X ULN
9. Subjects with Creatinine clearance greater than or equal to 45 mL per minute
10. Subjects of child-bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0.
11. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during treatment with the investigational product) practicing two acceptable methods of contraception during the study and at least 6 months after the last dose of study medication. Female subjects of non-child bearing potential or who have completed menopause are not required to use effective method of contraception during the study.
Acceptable methods of contraception are:
a. Hormonal method (including oral, vaginal ring, transdermal patch, implanted or injection) started at least 7 days prior to Day 0 plus one barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female or male condom)
b. Intrauterine device (IUD) or intrauterine system placed at least 7 days prior to Day 0.
c. Two barrier method used together (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, male or female condom)
d. Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that subject) plus one additional contraception method (hormonal or barrier method)
e. Documented tubal sterilization (tubal ligation or trans cervical tubal occlusion with documentation of occlusion 6 months post-procedure)
f. Total abstinence; partial abstinence is not acceptable (no sex or genital contact with a male partner)
12. No history of addiction to any recreational drug or drug dependence or alcohol addiction within past one year.
13. Subject should have recovered from the toxicity or adverse effects of previous radiation, surgery and/or chemotherapy as per investigators assessment before administration of study intervention.
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Paclitaxel, other taxane products or the components of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) or to any of the excipients.
2. Subjects with history of other malignancy in the past.
3. History or presence of sepsis or pneumonitis.
4. Subjects with ≥ Grade 2 peripheral neuropathy.
5. Presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
6. Subjects with known history or current symptoms of unstable angina or myocardial infarction within the past 6 months prior to screening visit.
7. Subjects with electrocardiographic evidence of acute ischemic or active conduction system abnormalities at screening assessment.
8. Subjects taking any of the inhibitors or inducers of either CYP2C8 or CYP3A4.
9. Known CNS metastasis.
10. Subjects with current clinical or laboratory evidence of active infection
11. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
12. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
13. Surgical or other non-healing wounds.
14. Participation in any clinical study within 90 days before the first dose of Investigational Product.
15. Loss of ≥350 ml (1 unit) of blood within 90 days before the first dose of Investigational Product.
16. 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.
17. Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable) and fatigue (Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V 5.0).
18. Pregnant or lactating women.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Establish the bioequivalence between the Test and the Reference product based on ln-transformed pharmacokinetic parameters Cmax, AUC0-t, and AUC0-inf for unbound and total paclitaxel  Per Period Total 23 blood sample till 120hrs will be collected including pre dose sample.  
 
Secondary Outcome  
Outcome  TimePoints 
Assess safety & tolerability of test product compared to reference product by monitoring adverse events.  08 Weeks per patients. 
 
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" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Anbison Lab. has developed the test product Paclitaxel 100 mg/vial injectable suspension similar to that of the reference product ABRAXANE® 100mg/vial for Injectable suspension of Celgene Corporation Summit, NJ 07901 for USFDA regulatory submission.

This study is being conducted to characterize the pharmacokinetic profile of Sponsor’s test product in comparison to the reference product after single intravenous infusion at a dose of 260 mg/m2 in female subjects with Breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy to assess the bioequivalence.

Study is designed as per USFDA OGD recommendation.

 

 

 
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