CTRI/2025/08/092690 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On:
11/02/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Bioequivalence Study of Doxorubicin 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride) in Female Participants with Breast or Ovarian Cancer.
Scientific Title of Study
A Randomized, Open-Label, Three-Period, Two-Treatment, Three-Sequence, Three-Way, Crossover, Reference Replicate, Multicenter, Bioequivalence Study of Doxorubicin 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride) of Emcure Pharmaceuticals Ltd., India with CAELYX 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride) Marketing Authorization Holder Baxter Holding B.V., Kobaltweg 49, 3542 CE Utrecht, Netherlands in Female Participants with Breast or Ovarian Cancer.
Institutional Ethics Committee ERODE CANCER CENTRE
Approved
Institutional Ethics Committee OCH and RC
Approved
Institutional Ethics Committee, Utkal Hospital
Approved
Institutional Ethics Committee,Aram Hospital
Approved
Manavata Clinical Research Institute Ethics Committee,
Approved
Netaji Polyclinic Institutional Ethics Committee
Approved
PP Maniya Hospital Ethics committee
Approved
Shubham Sadbhawana Super Speciality Hospital Ethics committee
Approved
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
CAELYX 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride)
2 mg/ml solution for infusion, to be administered at dosing interval of 28 days for a period of 3 months
Intervention
Doxorubicin 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride)
2 mg/ml solution for infusion, to be administered at dosing interval of 28 days for a period of 3 months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Female
Details
1. Female participant who is either non-pregnant, non-lactating or of non-childbearing potential between 18-75 years (both inclusive) of age.
2. Participant having histologically or cytologically confirmed either of the following cancer.
a. metastatic breast cancer or
b. advanced ovarian cancer failing standard first-line therapy i.e., platinum-based chemotherapy.
3. Participant with Body Mass Index (BMI) between 18 to 30 kg/m2 (both inclusive).
4. Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Non-smoker and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to screening).
6. Participant with left ventricular ejection fraction (LVEF) greater than or equals to 50 percent within normal limits of the institution as determined by multiple uptake gated acquisition (MUGA) or echocardiography.
7. Participant willing to not change their concurrent medications during the study and able to comply with study requirements and assessments.
8. Participant with acceptable hematologic status during screening:
a. Neutrophils greater than or equals to 1500 cells/mm3
b. Platelet count greater than or equals to 100,000/mm3
c. Hemoglobin greater than or equals to 9 gm/dL
9. Participant with acceptable liver function at screening:
a. Alanine aminotransferase less than or equals to 2.0 x ULN
b. Aspartate aminotransferase less than or equals to 2.0 x ULN
c. Bilirubin less than 1.2 mg per dL
d. Alkaline phosphatase less than or equals to 2.0 x ULN (less than or equals to 5 x ULN for bone metastasis)
10. Participant with Creatinine clearance greater than or equals to 30 mL per minute at screening.
11. Participant with life expectancy of at least 6 months at the time of screening.
12. Female participants with postmenopausal status or Female participant of child-bearing potential with negative pregnancy test [negative serum pregnancy test (beta-hCG) at Screening, and negative urine pregnancy test prior to each dose of study drug] must agree to practice an acceptable method of contraception throughout the study period. Women who are not postmenopausal greater than or equals to 52 weeks or surgically sterilized (e.g., bilateral tubal ligation) are considered of childbearing potential.
13. Participant willing and able to adhere to all protocol requirements and study procedures throughout the study.
14. Participant willing to provide informed consent to participate in the study.
ExclusionCriteria
Details
1. Participant with history of allergy or hypersensitivity reactions to a conventional formulation of doxorubicin HCl or any components of doxorubicin hydrochloride liposome injection
2. Participant with prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
3. Participant with active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P. carinii or other microorganism if under treatment with myelotoxic drugs.
4. Participant with receipt of cyclophosphamide, calcium channel blockers, and other potential cardiotoxic drugs for 2 weeks prior to dosing of Investigational Product, and during the study.
5. Participant with history of other malignancies in the last 5 years (Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible).
6. Participant who received liposomal doxorubicin HCl in the past and had a required dose reduction to below 50mg/m2, or whose disease has progressed or recurred after treatment with liposomal doxorubicin.
7. Participant who received previous chemotherapy less than 4 weeks prior to dosing of Investigational product.
8. Participants with clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease as per judgement of the investigator.
9. Participant with history of alcohol or drug addiction or use of any recreational drug within past one year.
10. Participants who donated 350 mL or more of blood in the 90 days before Period-I dosing.
11. Participant with use of CYP3A4 enzyme-inhibitors/inducers in the previous 30 days before day 1 of this study. They can be allowed, if they are kept constant in the last 30 days and are expected to remain constant during the study period.
12. Participant who has received treatment with radiation therapy or had surgery within one month prior to randomization.
13. Participant with prolonged (QTc greater than 450msec) or clinically significant ECG changes as per judgement of the investigator. QT interval will be calculated with Bazetts Formula.
14. Participant with allergy or hypersensitivity of Dexamethasone and ondansetron.
15. Participant with NYHA (New York State Heart Association) Class II-IV heart failure.
16. Participant with history of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
17. Participation in any other investigational clinical study within 30 days prior to randomization.
18. Participant with any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the patients participation in this study.
19. Use of grapefruit and grapefruit containing products within 07 days prior to randomization.
20. Participant with any other condition that, in the investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve objectives of the study.
21. Pregnant or lactating women participants.
22. Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
23. Participant with known central nervous system metastasis.
24. Participant 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).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the bioequivalence of the test product (Doxorubicin 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride) of Emcure Pharmaceuticals Ltd., India) with reference product (CAELYX 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride); Marketing Authorization Holder Baxter Holding B.V., Kobaltweg 49, 3542 CE Utrecht, Netherlands) in female participants with breast or ovarian cancer.
16 Weeks
Secondary Outcome
Outcome
TimePoints
To assess the safety of study products.
16 weeks
Target Sample Size
Total Sample Size="63" Sample Size from India="63" 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)
01/11/2025
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="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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
A Randomized, Open-Label, Three-Period, Two-Treatment, Three- Sequence, Three-Way, Crossover, Reference Replicate, Multicenter, Bioequivalence Study of Doxorubicin 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride) of Emcure Pharmaceuticals Ltd., India with CAELYX 2 mg/Ml concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride) Marketing Authorization Holder Baxter Holding B.V., Kobaltweg 49, 3542 CE Utrecht, Netherlands in Female Participants with Breast or Ovarian Cancer.
Objective:
1. To evaluate the bioequivalence of the test product (Doxorubicin 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride) of Emcure Pharmaceuticals Ltd., India) with reference product (CAELYX 2 mg/mL concentrate for solution for infusion (Pegylated liposomal doxorubicin hydrochloride); Marketing Authorization Holder Baxter Holding B.V., Kobaltweg 49, 3542 CE Utrecht, Netherlands) in female participants with breast or ovarian cancer.