Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034138
Status:
TERMINATED
Last Update Posted:
2007-12-18
First Post:
2002-04-23
Brief Title:
A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B4313 in Patients With Ovarian Epithelial Carcinoma
Sponsor:
Unither Pharmaceuticals
Organization:
Unither Pharmaceuticals
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
closed by sponser
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will compare the pharmacokinetic profile of OvaRex MAb-B4313 ascites fluid product and OvaRex MAb-B4313 cell culture product Safety and immune responses following treatment with the cell culture product will be evaluated
Detailed Description:
This is a prospective open-label randomized parallel group Phase 12 study in female patients with Stage IIIIV epithelial ovarian cancer The study will compare the pharmacokinetic profile of OvaRex MAb-B4313 ascites fluid product and OvaRex MAb-B4313 cell culture product The study will also evaluate the safety of the cell culture product and the immune responses in patients following treatment The study is being conducted in three phases
1 The pharmacokinetic assessment phase will include at least 24 patients who will be randomized into two treatment groups to receive a single 2 mg dose of either ascites fluid product or cell culture product
2 The treatment phase will continue administration of two more monthly doses weeks 4 and 8 and all patients will receive cell culture product Study patients will be followed for safety and immune response through week 20
3 The continuation phase will continue administration of cell culture product at the discretion of the investigator on a quarterly schedule for up to 104 weeks in eligible patients who tolerate therapy Patients who continue treatment will be followed for serious adverse events and all patients will be followed for survival for up to 2 years after first treatment
1 The pharmacokinetic assessment phase will include at least 24 patients who will be randomized into two treatment groups to receive a single 2 mg dose of either ascites fluid product or cell culture product
2 The treatment phase will continue administration of two more monthly doses weeks 4 and 8 and all patients will receive cell culture product Study patients will be followed for safety and immune response through week 20
3 The continuation phase will continue administration of cell culture product at the discretion of the investigator on a quarterly schedule for up to 104 weeks in eligible patients who tolerate therapy Patients who continue treatment will be followed for serious adverse events and all patients will be followed for survival for up to 2 years after first treatment
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