Bioequivalence study of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) in ovarian cancer subjects whose disease has progressed or recurred after platinum-based chemotherapy under standard diet (non-high-fat) conditions Subjects.
Completed
- Conditions
- Malignant neoplasm of unspecifiedovary,
- Registration Number
- CTRI/2022/12/048463
- Lead Sponsor
- Alembic Pharmaceuticals Limited
- Brief Summary
This is randomized,open-label, balanced, multi-center, two-treatment, two-period, two-sequence, two-waycrossover, single-dose, bioequivalence study of Doxorubicin HydrochlorideLiposome Injection 20 mg/10 mL (2 mg/mL) manufactured by AlembicPharmaceuticals Limited, India with Doxorubicin Hydrochloride LiposomeInjection 20 mg/10 mL (2 mg/mL) manufactured by Sun Pharmaceutical Ind. Ltd.,India administered through intravenous infusion in ovarian cancer subjectswhose disease has progressed or recurred after platinum-based chemotherapyunder standard diet (non-high-fat) conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
- Subjects will be considered eligible for the study based on the following criteria.
- Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- Subject or caregiver able to communicate effectively with study personnel or investigator.
- Female subjects between 18 and 75 years of age, both inclusive and having Body mass index (BMI) greater than or equal to 17.00 calculated as weight in kg per height in m2.
- Histopathologically or cytologically confirmed ovarian cancer.
- Documented progressive or recurrent disease after treatment with platinum based chemotherapy and who are already receiving or scheduled to start therapy on doxorubicin hydrochloride (liposomal).
- Able and clinically indicated to receive the recommended minimum 2 cycles of liposomal doxorubicin HCl. 7.
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
- Life expectancy of greater than 180 days at the time of enrollment.
- Acceptable hematology status: a.
- Hemoglobin greater than or equal to 9.0 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 micro L 10.
- Acceptable liver function: a.
- Alanine aminotransferase less than or equal to 2.0 X ULN b.
- Aspartate aminotransferase less than or equal to 2.0 X ULN c.
- Bilirubin less than 1.2 mg per dL d.
- Subject with left ventricular ejection fraction greater than or equal to 50 percent by an echocardiogram (ECHO) during screening.
- Subjects with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0.
- Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing acceptable methods of contraception during the study and for 6 months after treatment discontinuation.
- Acceptable methods of contraception are a.
- Intrauterine device or intrauterine system b.
- Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) c.
- Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that subject) d.
- Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation e.
- Total abstinence partial abstinence is not acceptable 15.
- No history of addiction to any recreational drug or drug dependence or alcohol addiction.
Exclusion Criteria
- Subjects will be excluded from the study based on the following criteria: 1.
- Known hypersensitivity or contraindication including anaphylaxis to conventional or liposomal formulations of doxorubicin, anthracycline therapy or to any of their components.
- Subjects with prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
- Failure or Intolerance to Doxorubicin hydrochloride that causes severe cardiotoxicity.
- Note: Following conversion factor will be used to calculate total cumulative dose of doxorubicin.
- Anthracycline agentConversion factor Doxorubicin 1 Epirubicin 0.5 Daunorubicin 0.5 Idarubicin 2.0 Mitoxantrone 2.2 3.
- Subject with impaired cardiac function including any of the following conditions within 6 months prior to screening: a.
- Unstable angina b.
- QTc prolongation (QTc of >470 msec (calculated by Bazett formula)) or other significant ECG abnormalities c.
- Coronary artery bypass graft surgery d.
- Symptomatic peripheral vascular disease e.
- Myocardial infarction f.
- NYHA class II-IV heart failure g.
- Severe uncontrolled ventricular arrhythmias h.
- Clinically significant pericardial disease i.
- Electrocardiographic evidence of acute ischemic or active conduction system abnormalities 4.
- Receipt of any potential cardiotoxic drugs less than 2 weeks prior to dosing of Investigational Product.
- Subjects taking or scheduled to receive strong inducers and inhibitors of CYP3A4, CYP2D6 or P-gp 7.
- Pregnant or lactating women.
- Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism if under treatment with myelotoxic drugs.
- Known central nervous system metastasis.
- Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- Exceptions are alopecia (any grade is acceptable), Hemoglobin greater than or equal to 9.0 g/dL, 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).
- 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.
- Participation in any clinical study within 90 days before the first dose of Investigational Product.
- Has consumed any alcohol or alcoholic products within 48 hours prior to IP administration on Day 1.
- Has consumed any xanthine containing food or beverages (tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products (like pan, pan masala, gutkha), beedi, cigarette within 24 hours prior to IP administration on Day 1.
- Has consumed grapefruit or grapefruit products, pomelo-containing food or fluids and recreational drugs within 1 week prior to IP administration on Day 1.
- Subject with confirmed novel coronavirus infection (COVID-19).
- Subject who have taken vaccination for COVID-19 within 14 days before the day of first dosing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) manufactured by Alembic Pharmaceuticals Limited, India with Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) manufactured by Sun Pharmaceutical Ind. Ltd., India administered through intravenous infusion in ovarian cancer subjects whose disease has progressed or recurred after platinum-based chemotherapy under standard diet (non-high-fat) conditions A total of Twenty four (24) blood samples of 04.0 mL each will be collected for PK analysis in each period of the study. A total of 48 blood samples will be collected during the study.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of subjects A total of twenty four (24) blood samples of 04.0 mL each will be collected for PK analysis in each period of the study. A total of 48 blood samples will be collected during the study.
Trial Locations
- Locations (19)
KLEs Dr. Prabhakar Kore Hospital and MRC
🇮🇳Belgaum, KARNATAKA, India
Lifeline Diagnostic Centre cum Nursing Home
🇮🇳Kolkata, WEST BENGAL, India
Darakh Nursing Home and Kidney Stone Centre
🇮🇳Aurangabad, MAHARASHTRA, India
Erode Cancer Centre
🇮🇳Erode, TAMIL NADU, India
Government Medical College and Research Institute
🇮🇳Nagpur, MAHARASHTRA, India
HCG Cancer Centre
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
HCG City Cancer Centre
🇮🇳Krishna, ANDHRA PRADESH, India
HCG Manavata Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
Indrayani Hospital & Cancer Institute
🇮🇳Pune, MAHARASHTRA, India
K.R. Hospital Medical College and Research Institute
🇮🇳Mysore, KARNATAKA, India
Scroll for more (9 remaining)KLEs Dr. Prabhakar Kore Hospital and MRC🇮🇳Belgaum, KARNATAKA, IndiaDr Maheshkumar KalloliPrincipal investigator9945014996mahesh.kalloli@gmail.com