Status:
TERMINATED
A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness between CAELYX and topotecan hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma following failure of firs...
Detailed Description
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), comparative bridging study (a supplemental study which performs to pr...
Eligibility Criteria
Inclusion
- Histological diagnosed with epithelial ovarian carcinoma with measurable disease
- Recurrent epithelial ovarian carcinoma or disease progression following failure of first-line, platinum-based chemotherapy with no more than one prior platinum based regimen therapy
- Adequate laboratory values of bone marrow function, renal function, liver function, and echocardiogram tests
- Agrees to use protocol-defined effective contraception. A woman must agree not to donate eggs (ova, oocytes) for the purpose of assisted reproduction
- Disease-free from prior malignancies for more than 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Exclusion
- Females who are pregnant or breast feeding or planning to become pregnant while enrolled in this study or within 1 year after the last dose of study medication
- Myocardial infarct within 6 months before enrollment, class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Uncontrolled systemic infection that requires systemic anti-infective treatment
- Prior therapy with CAELYX or topotecan HCl
- Prior chemotherapy within 28 days of first dose of study medication (or 42 days if participant has received a nitrosourea or mitomycin)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01840943
Start Date
June 1 2013
End Date
August 1 2014
Last Update
December 23 2015
Active Locations (7)
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1
Beijing, China
2
Changsha, China
3
Guangzhou, China
4
Jinan, China