Health Condition 1: null- Female patients with ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy and who are already receiving or scheduled to start therapy
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL: Doxorubicin Hydrochloride liposome injection 20 mg/10 mL as per randomization schedule at a dose of 50 mg/m2 (Single dose)admin
Sponsors
Emcure Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Availability of volunteer for the entire study period and willingness to adhere to Protocol requirements as evidenced by the written ICF duly signed by the volunteer. 2. Female, 18 to 75 years of age (both inclusive) and having a Body Mass Index (BMI) at least 17 kg/m2. 3. Have histologically or cytologically confirmed ovarian cancer 4. Ovarian cancer has progressed or recurred (by CT,MRI confirmation within the past 6-8 weeks) after Platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection 50 mg/m2 dose as monotherapy as per Investigator judgment. 5. Patients with life expectancy for at least 3 months. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (The woman should be ambulatory, capable of all self care, up for more than 50 percent of waking hours. She may or may not be able to carry out any work activities). 7. Either the female is of non-child bearing potential (females having documented history of surgical sterilization or are postmenopausal (12 months of amenorrhea after the last menstrual period) or if the female is of child bearing potential, then she is eligible if Patient has used an effective method of contraception or abstinence from at least 4 weeks prior to study drug administration. Effective method includes Tubal sterilization (tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1) Intrauterine Device (IUD) Progestin Implant (i.e. Implanon or its equivalent) Progestin injection or progestin oral contraceptive pill and one barrier method (cervical cap, diaphragm, contraceptive sponge or vaginal spermicide and a male or female condom) Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge or vaginal spermicide and a male or female condom)
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of hypersensitivity or idiosyncratic reactions to a conventional or novel liposomal formulation of Doxorubicin HCl and its excipients or to the components of the RLD or reference standard product drug. 2. Prior Doxorubicin (or other anthracyclines) exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment. 3. Patients who require any dose modifications (Dose other than 50 mg/m2) 4. If any patient whose weight changes during the study requiring a ± 5% dose adjustment will be discontinued from the study and excluded from the analysis. 5. If any signs or symptoms of extravasation have occurred, the infusion should be immediately terminated and the patient will be discontinued from the study and excluded from the analysis. 6. Pregnant or lactating woman. 7. Females of childbearing potential unwilling to use acceptable contraception (as identified in the protocol) throughout the trial and for 6 months after the last dose of study drug. 8. Use of strong hepatic enzyme modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Ketoconazole, Itraconazole, Clarithromycin, Erythromycin, Ritonavir, Indinavir, Nelfinavir, Saquinavir, Nefazodone, Diltiazem, Verapamil, Rifampicin and Cyclosporine) in the previous 30 days before the study. 9. Have received treatment with radiation therapy, chemotherapy, immunotherapy in less than 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C) Have major surgery, other than diagnostic surgery, within 4 weeks prior to study entry. 11. Patients who have participated in another clinical trial within 90 days of study start. 12. Donation of more than 350 ml of blood within 90 days prior to receiving the first dose of IMP for the current study. 13. Known active brain metastasis including leptomeningeal involvement (patients with brain metastases can only be enrolled if they are treated and stable for >8 weeks and who currently do not require steroid or radiation therapy) 14. Clinically significant Pre-existing toxicity by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria. Mild to moderate Pre-existing toxicity can be allowed only if in the opinion of investigator, it will not require dose modification, will not interfere with the study assessment and will not pose undue safety concerns to the patient. (â??Palmarâ??plantar erythrodysesthesiaâ?? and â??Stomatitisâ?? of grade 2 and above requires dose modification, hence not allowed). 15. Patients with significantly impaired hepatic or renal function. 16. Laboratory parameters: 1)Patients with ANC 2)Platelet count 3)Hemoglobin 4)Bilirubin >2.5 x ULN or if any dose modification required due to abnormal bilirubin levels 5)Alkaline phosphatase, ALT, AST > 2.5 x ULN For other laboratory parameters, the patient can be included if the values are clinically non-significant in the opinion of investigator. 17. Have seizure disorders requiring anticonvulsant therapy. 18. Have known infection with human immunodeficiency virus (HIV I and II antibodies), Hepatitis B or Hepatitis C 19. Have an active, uncontrolled bacterialviral, fungal, or other opportunistic infections requiring systemic therapy 20. Active opportunistic infec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL or 50 mg/25 mL (Dose 50mg/m2) of Emcure Pharmaceuticals Ltd., India, compared to that of Doxorubicin Hydrochloride Liposome Injection for Intravenous Infusion 20 mg/10 mL or 50 mg/25 mL (Dose 50mg/m2) Manufactured By Sun Pharmaceutical Ind. Ltd., IndiaTimepoint: Pre dose 0.00 and post dose at 00.17, 00.33, 00.50, 00.67, 00.83, 01.00, 01.08, 01.25, 01.50, 01.75, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 48.00, 96.00, 144.00, 192.00, 240.00, 288.00 and 336.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single dose administered in female patients with ovarian cancer under fasting condition.Timepoint: Vitals will be measured at check-in, prior to dosing and at approximately 2.00, 4.00, 8.00 and 12.00 hours after each dose, before check-out and each ambulatory visit in each period. Pre-dose vitals will be measured within 2 hours prior to dosing. A window period of ± 40 minutes hour from the scheduled time point is allowed for post dose vitals measurements. | — |
Countries
India
Contacts
Public ContactDr K Someswara Rao
Panexcell Clinical Lab Private Limited
Outcome results
None listed