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CTRI Number  CTRI/2025/07/090966 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Other 
Public Title of Study   Effect of paclitaxel protein-bound particles for injectable suspension in breast cancer patients. 
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), 100 mg/vial of Alembic Pharmaceuticals Ltd, India with ABRAXANE for Injectable Suspension 100 mg/vial of Bristol-Myers Squibb Company, Princeton, NJ 08543 USA in Patients with Metastatic Breast Cancer Under Standard Diet (Non-High-Fat) Conditions. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No.: C2A02294 Version: 02 Date: 07 Mar 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Domadia 
Designation  Vice President- Global Clinical Operations 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Ltd., Cliantha Corporate, TP 86, FP 28/1, Off S.P Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  2717698500  
Fax    
Email  ddomadia@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaydipsinh Gohil 
Designation  Manager (Medical Monitor) 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Ltd., Cliantha Corporate, TP 86, FP 28/1, Off S.P Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  9409201420  
Fax    
Email  jbgohil@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Mr Devesh Verma 
Designation  Director 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Ltd., Cliantha Corporate, TP 86, FP 28/1, Off S.P Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  9712908404  
Fax    
Email  dverma@cliantha.com  
 
Source of Monetary or Material Support  
Alembic Pharmaceuticals Limited, Alembic Road, Vadodara - 390 003 Gujarat, India 
 
Primary Sponsor  
Name  Alembic Pharmaceuticals Limited 
Address  Alembic Pharmaceuticals Limited, Alembic Road, Vadodara - 390003 Gujarat, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Prakash S S  K.R. Hospital Mysore Medical College & Research Institute  Dept. of Surgical Oncology, Room No.23, Ground Floor, Irwin Road, Mysore, Karnataka - 570001
Mysore
KARNATAKA 		 9901000559

prakashyesyes@yahoo.com 
Dr Anil Kumar MR  Oncoville Cancer Hospital & Research Centre  3rd Floor of Hospital Building, No 4 , 80. ft road , 7th block , 2nd Stage ,Naagarbhavi , Bengaluru , Karnataka - 560072
Bangalore
KARNATAKA 		 9739808502

dranil.onco@gmail.com 
Dr Minish Mahendra Jain  Prolife Cancer Centre and Research Institute  Basement of Hospital Building, 557A1,15C Jawaharlal Nehru road , Burhanj Baug , B-Colony Market yard , Gultekadi, Pune, Maharashtra - 411037
Pune
MAHARASHTRA 		 9823133390

dr.minishjainprolifehospital@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospitals and Critical Care (P) Limited  Room No.2, Annexure Building, Department of Medical Oncology, A/407, Saheed Nagar, Bhubaneswar, Odisha - 751007
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
Dr Rajender Singh Arora  Sujan Surgical Cancer Hospital and Amravati Cancer Foundation  01st Floor, 52/B, Shankar Nagar, Gopal Nagar, Amravati, Maharashtra - 444606
Amravati
MAHARASHTRA 		 9823097573

dr.rsarora@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Amravati Ethics Committee  Submittted/Under Review 
IEC -MMC and RI and Associated Hospitals   Submittted/Under Review 
IEC Dr. Mhaske Hospital and Research Centre  Submittted/Under Review 
Institutional Ethics Committee , Sparsh Hospitals  Approved 
Institutional Ethics Committee of OCH and RC  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ABRAXANE® for Injectable Suspension  Pack size: 100 mg/vial Dose: 260 mg/m2 via IV infusion Single dose  
Intervention  Paclitaxel protein-bound particles for injectable suspension (Albumin-Bound)   Pack size: 100 mg/vial Dose: 260 mg/m2 via IV infusion Single dose  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Female patient of 18 to 65 years of age (both inclusive).
2. Patient having histological or cytological confirmed breast cancer and who fulfill have the following;
a. After failure of combination chemotherapy for metastatic disease OR
b. Relapse within 6 months of adjuvant chemotherapy OR
c. Patient who is a candidate for albumin bound Paclitaxel therapy in accordance with the standard of care as per PI judgement according to NCCN Guideline.
Note: Prior therapy should have included an anthracycline unless clinically contraindicated for 2 a. and 2 b.
3. Body surface area (BSA) that is within 1.2 to 2.2 m2, calculated using the DuBois Formula (Appendix V).
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to 2 as per Appendix II.
5. Hematology/chemistry: Patient has adequate hematological, renal, and hepatic function as defined by the following laboratory values obtained at screening and prior to randomization (patients should not have received a transfusion within 7 days before the screening laboratory assessments):
a. Absolute neutrophil count (ANC) greater than or equals to 1,500 cells/mm3
b. Platelet count greater than or equals to 100,000 cells/mm3
c. Hemoglobin greater than or equals to 9 g/dL
d. Creatinine clearance greater than 30 mL per minute (using Cockcroft-Gault formula) Formula of creatinine clearance: Crcl equals to (140 - age) x body weight (Kilogram weight)/plasma creatinine (mg/dl) x 72 x 0.85 (considering female patients).
e. Total bilirubin less than or equals to 1.5 mg/dL
f. AST (SGOT) less than or equals to 100 U/L
g. ALT (SGPT) less than or equals to 100 U/L
h. Alkaline phosphatase less than or equals to 300 U/L
6. Patient with Serum albumin greater than or equals to 3.0 gm/dL at screening.
7. Patient with life expectancy of at least 6 months at the time of enrollment.
8. Female with postmenopausal status or female of child-bearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug. No history of pregnancy in last 30 days prior to randomization. Women who are not postmenopausal greater than or equals to 52 weeks or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) are considered of child-bearing potential.
9. Able and willing to adhere to all protocol requirements and study procedures throughout the study.
10. Patient/LAR willing to provide informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Patient with a history of other malignancies, except for adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, in situ carcinoma of the breast or other solid tumors with no evidence of recurrence for greater than or equals to 5 years.
2. Patient who has previously received a taxane within 30 days prior to randomization.
3. Patient who has not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by (National Cancer Institute-Common terminology criteria for Adverse Events) NCI-CTCAE, with the exception of alopecia.
4. The patient receives treatment with any:
a. Hormonal therapy within 2 weeks prior to randomization
b. Chemotherapy within 4 weeks prior to randomization
Note: Except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated.
c. Investigational drug or immunotherapy within 4 weeks prior to randomization.
d. Concurrent radiation therapy (except for palliative radiotherapy for bone pain which can be administered as clinically indicated).
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 3 or higher by NCICTCAE Version 5.0 or higher at Screening.
7. Abnormal ECG: QTc greater than 470 msec in patient at screening [QTc interval will be calculated with Bazetts Formula] (Refer Appendix IV).
8. Patient with known brain metastases, with the exception of patient who has completed surgery and/or radiotherapy at least 30 days prior to randomization, has completed any steroids as treatment for the metastases at least 30 days prior to randomization, and who is currently asymptomatic.
9. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator.
10. Known history or presence of Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.
11. Alcohol or drug abuse or dependence within one year prior to randomization.
12. Hypersensitivity or idiosyncratic reaction to Paclitaxel, its excipients, and/or related substances, including, albumin and PEG.
13. Patient may not participate in any other clinical investigational trial that involves administration of experimental therapy and/or the use of investigational devices with therapeutic intent within 30 days prior to randomization.
14. Pregnant or lactating female.
15. Patient with presence of uncontrolled hypertension or diabetes mellitus.
16. History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
17. Use of any strong inhibitor or inducer of CYP2C8 and CYP3A4 in the previous 14 days before randomization.
Note: If Patient on stable dosage regimen of moderate OR weak inhibitors/inducers of CYP2C8 and CYP3A4 since at least 1 month before randomization can be allowed; and same stable dosage regimen should be ensured during the study period.
18. Acute active infection requiring treatment within 14 days prior to randomization.
19. Patient has consumed any caffeine, xanthine containing food or beverages (tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products (like pan, pan masala, gutkha), beedi, cigarette, alcohol or recreational drugs within 24 hours prior to randomization.
20. Patient has consumed grapefruit or grapefruit products and pomelo-containing food or fluids within 07 days prior to randomization.
21. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 90 days prior to randomization.
22. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
23. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the patients participation in this study.
24. Any other condition that, in the Investigators judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the bioequivalence of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial of Alembic Pharmaceuticals Ltd, India with ABRAXANE® for Injectable Suspension 100 mg/vial of Bristol-Myers Squibb Company, Princeton, NJ 08543 USA in Patients with Metastatic Breast Cancer under standard diet (non-high-fat) conditions.
 		 96 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of study products.  96 hours  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/08/2025 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This study is being conducted to establish bioequivalence between Alembic product and the comparator product in Patients with Metastatic Breast Cancer under standard diet (non-high-fat) conditions. 
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