Status:
COMPLETED
Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer
Lead Sponsor:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment, two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference (R) formulations of dox...
Detailed Description
This study has an adaptive 2-stage design. Bioequivalence based on encapsulated doxorubicin will be tested at the end of Stage 1 . An interim analysis of free doxorubicin will be performed at the end ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02237690
Start Date
September 1 2014
End Date
August 1 2016
Last Update
June 5 2017
Active Locations (3)
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1
Cancer Institute& Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
QiLu Hospital of Shandong University
Jinan, Shandong, China, 250012