Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer

This is an interventional treatment trial for Ovarian Cancer Read More

Inclusion Criteria:

• Able to give written informed consent for participation in the trial;
• Females age 18 to 75 years, inclusive;
• Histologically or cytologically proven ovarian cancer, which has progressed or recurred by CT/MRI confirmation after platinum-based chemotherapy;
• ECOG (Eastern Cooperative Oncology Group) Performance Status 0 - 2;
• Patient is expected to be able to receive both doses of Doxorubicin Hydrochloride Liposome Injection and participate in the trial for at least 56 days.

• Urine pregnancy test before dosing of both cycle1 and cycle 2 must be negative (not including postmenopausal or surgically sterile women); Agree to use an approved method of birth control (condom with spermicide, diaphragm or cervical cap with spermicide, or intrauterine device); or patients of non-childbearing potential who are either surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or >1 year postmenopausal with follicle-stimulating hormone in the postmenopausal range;

  • 30days or 5 half-lives (whichever is longer) have elapsed from the completion of previous cancer therapy, and patients must have recovered to < Grade 2 or be at new stable baseline from any related toxicities;
• Adequate renal, hepatic and bone marrow function without blood product or hematopoietic growth factor support:
• Able to comply with study requirements in the opinion of the Principal Investigator

Exclusion Criteria:

• Significant allergy, hypersensitivity or idiosyncratic reactions to doxorubicin and/or any related compounds;
• History or presence of cardiac disease rated New York State Heart Association Classification class 2 or greater;
• Uncontrolled cardiac arrhythmia or other findings on screening electrocardiogram (ECG) which could, in the judgment of the Principal Investigator, put the patient at undue risk for participation in the trial;
• LVEF（left ventricular ejection fraction） below 50% or below institutional normal at screening;
• Prior radiation therapy to mediastinum;
• Concomitant use of other cytotoxic or cytostatic drugs or of radiotherapy;
• Active, uncontrolled infection, including opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, or P. carinii;
• Use of prescription or non-prescription herbal and dietary supplements, within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.