CTRI/2024/04/065727 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On:
13/10/2025
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
An Open Label, Multicenter, Randomized, Balanced, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover, Bioequivalence Study of Test Product Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-bound), for Intravenous Use (Manufactured by/for: Dr. Reddy’s Laboratories Ltd.) with Reference Product Abraxane® for Injectable Suspension (Paclitaxel Protein-bound Particles for Injectable Suspension) (Albumin-bound), for Intravenous Use (Abraxis BioScience, LLC, USA) in Breast Cancer Patients.
Clinical Research Department, 2nd floor, Surya Arcade, Opposite Nimani Bus Stand, Panchavati, Nashik-422003, Maharashtra, India Nashik MAHARASHTRA
8758052774
drmukulgharote.citius@gmail.com
Dr K Velavan
Erode Cancer Centre
Clinical Research Department, Room No. 33, Ground Floor, 1/393, Velavan nagar, Near Chintamani petrol bunk Perundurai Road, Thindal Medu,Thindal, Erode-638012, Tamilnadu, India Erode TAMIL NADU
9842822443
kvels@rediffmail.com
Dr G Raja
Government Royapettah Hospital
Clinical Research Room, Room No. 302, 3rd Floor, Cancer Block, No:1, West cott road, Royapettah, Chennai, Tamil Nadu-600014
Chennai TAMIL NADU
9841107677
rajaresearch17@gmail.com
Dr Rajnish Vasant Nagarkar
HCG Manavata Cancer Center Hospital
1st Floor, Clinical Research Department, Behind Shivang Auto, Mumbai Naka, Nashik-422002 Maharashta, India Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr Prakash S S
K.R Hospital - MMCSRI
K.R Hospital-MMCSRI, Dept. of Surgical Oncology, ground floor, next to Dept. of radiology K.R. Hospital, Mysore- 570001
Mysore KARNATAKA
9901000559
prakashyesyes@yahoo.com
Dr Santosh Vandanasetti
Kailash Cancer hospital & Research center
1st Floor, Clinical Research Department of Kailash Cancer and Research Centre, Muni Seva Ashram, Goraj, Waghodia, Vadodara-391760, Gujarat, India. Vadodara GUJARAT
9427423693
vandanasetti.santhosh@greenashram.org
Dr Praveen Adusumilli
Kolhapur Cancer Centre Hospital Pvt Ltd.
A/p. R.S. No. 238, Opp. Mayur Petrol Pump, Gokul Shirgaon, Kolhapur - 416234, Maharashtra, India Kolhapur MAHARASHTRA
9100755777
Praveen.adusumilli@kolhapurcancercentre.com
Dr Murali Subramanian
Medstar Speciality Hospital
Clinical Research department, 2nd floor, #641/17/1/3, Kodigehalli main road, Sahakarnagar, Bangalore, 560092, Karnataka, India Bangalore KARNATAKA
9945813327
medstarclinicalresearch@gmail.com
Dr Anil Kumar M R
Oncoville Cancer Hospital and Research center
3rd Floor, Clinical Research Department, No 4, 80 ft road, 7th block, Nagarbhavi, 2nd stage, Bangalore 560072, Karnataka, India
Bangalore KARNATAKA
9739808502
dranil.onco@gmail.com
Dr Aniket Thoke
Sanjeevani CBCC USA Cancer Hospital
Clinical Research Department, Room no. 216, 1st floor, Admin Building, In Front of Jain Mandir, Dawada Colony Pachpedi Naka Raipur-492001 Chhattisgarh, India Raipur CHHATTISGARH
9752929741
drthoke@gmail.com
Dr Yamini Patel
SSG Hospital
Clinical Study Room, 2nd floor, Department of Radiation Oncology, SSG Hospital, Jail Road, Indira Avenue, Vadodara, Gujarat-390001, India Vadodara GUJARAT
9426367470
dr_yaminipatel@yahoo.com
Dr Rajendrasinh Arora
Sujan Surgical Cancer Hospital & Amaravati cancer foundation
52/B, Shankar Nagar, Main Road, Amravati 444605 Amravati MAHARASHTRA
9823097573
rsaroradr@gmail.com
Dr Patil Tushar Vishwasrao
Vishwaraj Hospital
Clinical Research Department, Third Floor, Gate no 499, Kadamvakvasti, Solapur Road, Loni kalbor, Pune -41220l, Maharshtra, India Pune MAHARASHTRA
1. Female patient of 18 to 65 years of age (both inclusive). 2. Patient having histologically or cytologically confirmed breast cancer and who fulfill any one of the following: a. Failure of combination chemotherapy for metastatic disease OR b. Relapse within six months of adjuvant chemotherapy OR c. Patient who is a candidate for albumin bound Paclitaxel therapy as standard of care as per PI judgement according to NCCN Guideline. Note: Prior therapy should have included an anthracycline unless clinically contraindicated. This is applicable for 2a and 2b only. 3. Adequate hematological, renal, and hepatic function as defined by the following screening 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) ≥ 1,500 cells/mm3 (1.5x109 /L) b. Platelet count ≥ 100,000 cells/mm3 (100x109 /L) c. Hemoglobin ≥ 9 g/dL d. Creatinine clearance more than 30 mL per minute 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 ≤ 1.5 mg/dL, AST (SGOT) ≤ 100 U/L, ALT (SGPT) ≤ 100 U/L, Serum albumin ≥ 3.0 gm/dL, Alkaline phosphatase ≤ 300 U/L. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix II). 5. All other clinical laboratory values deemed normal or not clinically significant judged by the Investigator. 6. Body surface area (BSA) that is within 1.2 to 2.2 m2 , calculated using the Du Bois Formula (Appendix III). 7. Patient with life expectancy of at least 3 months at the time of enrollment. 8. Female patient with postmenopausal status or female patient of childbearing potential with negative pregnancy test [negative serum pregnancy test (β-hCG) at screening, and negative urine pregnancy test prior to each dose of study drug] must agree to practice a medically 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 day prior to randomization. Women who are not postmenopausal ≥ 52 weeks or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) are considered of child-bearing potential. 9. Patient who had taken COVID-19 vaccine, must have recovered from vaccine related adverse events before being screened for the study. 10. Patient willing and able to adhere to all protocol requirements and study procedures throughout the study. 11. Ability to comprehend and be informed of the nature of the study, as assessed by study clinic staff
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) including, albumin and PEG 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), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological (e.g., bleeding diathesis or coagulopathy) disease or condition other than breast cancer unless determined as not clinically significant by the Investigator. 3. Patient with presence of uncontrolled hypertension or diabetes mellitus. 4. History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer. 5. Ongoing or planned lactation during study period. 6. Receipt of a taxane within the 30 days prior to randomization. 7. The patient receives treatment with any: a. Hormonal therapy 2 weeks prior to first dose b. Chemotherapy (except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated) 4 weeks prior to first dose c. Investigational drug or immunotherapy within 4 weeks prior to first dose d. Concurrent radiation therapy (except for palliative radiotherapy for bone pain which can be administered as clinically indicated) 8. Incomplete recovery from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by current version of CTCAE, with the exception of alopecia. 9. Patient with preexisting peripheral neuropathy of NCI toxicity scale greater than 2. 10. Major surgery within 30 days prior to randomization, or incomplete recovery from prior major surgery. 11. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator. 12. Known history or presence of: a. Infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C b. Alcohol or drug abuse or dependence within one year prior to randomization 13. Patient with known CNS metastasis. 14. Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or the use of investigational devices with therapeutic intent within 30 days or period equivalent of 5 half-lives of the investigational intervention prior to randomization and while enrolled in this study. 15. Receipt of any known CYP2C8 and CYP3A4 inhibitor (e.g., ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or inducer (e.g., rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) in the previous 14 days before randomization. 16. Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing and fatigue). 17. Consumption of any grapefruit, star fruit, grape fruit juice, seville oranges, and seville orange juice and its products within 07 days prior to randomization. 18. Ingestion of any alcoholic food (e.g. plum pudding, cake, chocolate containing alcohol) or beverage containing alcohol or utilize recreational drugs, caffeine or xanthine containing food or beverage within the 48 hours prior to randomization. 19. 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. 20. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 21. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the patient’s participation in this study. 22. 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Cmax, AUC0-t and AUC0-inf
Considering the minimum washout period, expected study duration of clinical part is 9 week from the day of screening
Secondary Outcome
Outcome
TimePoints
Tmax, t1/2, Kel, AUC%Extrap_obs, Vd and Cl
Considering the minimum washout period, expected study duration of clinical part is 9 week from the day of screening
Target Sample Size
Total Sample Size="70" Sample Size from India="70" Final Enrollment numbers achieved (Total)= "70" Final Enrollment numbers achieved (India)="70"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is designed to evaluate the bioequivalence of
test product paclitaxel protein-bound particles for injectable suspension
(albumin-bound), for intravenous use (manufactured by/for: Dr. Reddy’s
Laboratories Ltd.) with reference product Abraxane® for injectable suspension (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound), for
intravenous use (Abraxis BioScience, LLC, USA) in breast cancer patients. A
total of 70 female patients of 18-65 years of age will be enrolled. Total
expected duration will be 57 days for each subject. The study will be conducted
in multicenter from 8-10 sites across India to recruit 70 subjects for trial.