Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216645
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-09-13
Brief Title:
Phase II Clinical Study of Pegylated Liposomal Doxorubicin Hydrochloride Injection as 2nd-line or Later Therapy in Patients With Mullerian Carcinoma Epithelial Ovarian Carcinoma Primary Carcinoma of Fallopian Tube Peritoneal Carcinoma Having Prior Platinum-Based Chemotherapy
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
Open-label Study to Verify Effectiveness Safety of Pegylated Liposomal Doxorubicin 50 mgm2 Administered Every 4 Weeks to Patients With Mullerian Carcinoma Epithelial Ovarian Carcinoma Primary Carcinoma of Fallopian Tube Peritoneal Carcinoma Who Have Undergone Prior Platinum-based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effectiveness and safety of pegylated liposomal doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma This clinical study is a multi-center non-randomized open-label study in Japanese patients with Mullerian carcinoma including epithelial ovarian carcinoma primary carcinoma of fallopian tube peritoneal carcinoma with a prior history of platinum-based chemotherapy Eighty patients will be administered intravenously at least two cycles of 50 mgm2 of pegylated liposomal doxorubicin hydrochloride every 4 weeks to investigate the effectiveness and safety of the treatment
Detailed Description:
Pegylated liposomal Doxorubicin hydrochloride is intended to change the pharmacokinetics of conventional doxorubicin in the blood and to improve the safety and effectiveness of the drug Pegylated liposomal doxorubicin hydrochloride has been approved in many countries including US and EU becoming a standard drug for 2nd-line therapy in ovarian cancer and AIDS-related Kaposis Sarcoma This clinical study was planned to assess effectiveness and safety for Japanese patients with Müllerian carcinoma including epithelial ovarian carcinoma primary carcinoma of fallopian tube peritoneal carcinoma who had a prior history of receiving platinum-based chemotherapy such as Cisplatin which is considered to be the standard chemotherapy for ovarian carcinoma In this study at least two cycles of pegylated liposomal doxorubicin hydrochloride 50 mgm2 will be intravenously administered to 80 patients every 4 weeks These patients include twenty 2nd-line platinum-sensitive and sixty platinum-resistant 2nd-line or 3rd-line patients Pegylated liposomal doxorubicin hydrochloride 50 mgm2 will be given by intravenous drip infusion on day 1 After this a 27-day drug-free period will be followed as one cycle At least two cycles will be given as long as the patient does not meet the discontinuation criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None