CTRI/2025/08/092690RecruitingNot Applicable
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.
Emcure Pharmaceuticals Ltd.11 sites in 1 country63 target enrollmentStarted: November 1, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Emcure Pharmaceuticals Ltd.
- Enrollment
- 63
- Locations
- 11
- Primary Endpoint
- 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.
Study Overview
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:
-
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.
-
To assess the safety of study products.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female participant who is either non-pregnant, non-lactating or of non-childbearing potential between 18-75 years (both inclusive) of age.
- •Participant having histologically or cytologically confirmed either of the following cancer.
- •metastatic breast cancer or b.
- •advanced ovarian cancer failing standard first-line therapy i.e., platinum-based chemotherapy.
- •Participant with Body Mass Index (BMI) between 18 to 30 kg/m2 (both inclusive).
- •Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •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.
- •Participant willing to not change their concurrent medications during the study and able to comply with study requirements and assessments.
- •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
- •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)
- •Participant with Creatinine clearance greater than or equals to 30 mL per minute at screening.
- •Participant with life expectancy of at least 6 months at the time of screening.
- •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.
- •Participant willing and able to adhere to all protocol requirements and study procedures throughout the study.
- •Participant willing to provide informed consent to participate in the study.
Exclusion Criteria
- •Participant with history of allergy or hypersensitivity reactions to a conventional formulation of doxorubicin HCl or any components of doxorubicin hydrochloride liposome injection
- •Participant with prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
- •Participant with active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P.
- •carinii or other microorganism if under treatment with myelotoxic drugs.
- •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.
- •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).
- •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.
- •Participant who received previous chemotherapy less than 4 weeks prior to dosing of Investigational product.
- •Participants with clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease as per judgement of the investigator.
- •Participant with history of alcohol or drug addiction or use of any recreational drug within past one year.
- •Participants who donated 350 mL or more of blood in the 90 days before Period-I dosing.
- •They can be allowed, if they are kept constant in the last 30 days and are expected to remain constant during the study period.
- •Participant who has received treatment with radiation therapy or had surgery within one month prior to randomization.
- •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.
- •Participant with allergy or hypersensitivity of Dexamethasone and ondansetron.
- •Participant with NYHA (New York State Heart Association) Class II-IV heart failure.
- •Participant with history of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
- •Participation in any other investigational clinical study within 30 days prior to randomization.
- •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.
- •Use of grapefruit and grapefruit containing products within 07 days prior to randomization.
- •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.
- •Pregnant or lactating women participants.
- •Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •Participant with known central nervous system metastasis.
- •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).
Outcomes
Primary Outcomes
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.
Time Frame: 16 Weeks
Secondary Outcomes
- To assess the safety of study products.(16 weeks)
Investigators
Dr Dharmesh Domadia
Cliantha Research Limited
Study Sites (11)
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