Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01279291
Status:
TERMINATED
Last Update Posted:
2024-04-26
First Post:
2011-01-11
Brief Title:
Study of Anti-HB-EGF Antibody KHK2866 in Subjects With Advanced Solid Tumors and Ovarian Cancer
Sponsor:
Kyowa Kirin Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to the inability to determine an acceptable dose with the potential for further study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a two-part Phase 1 open-label multicenter dose escalation study of KHK2866 as monotherapy in patients with advanced solid tumors and in combination with chemotherapy in subjects platinum-sensitive and platinum-resistant ovarian cancer
Detailed Description:
During Phase 1a groups of eligible patients with advanced solid tumors will receive KHK2866 as monotherapy in escalating doses The Phase 1b portion will enroll patients with ovarian cancer who will receive KHK2866 in combination with one of three chemotherapy regimens Arms gemcitabinecarboplatin platinum-sensitive weekly paclitaxel platinum-resistant or pegylated liposomal doxorubicin platinum-resistant Escalating doses of the combination of KHK2866 and the chemotherapy regimen will given to two groups of subjects per Arm The goal of the study is to learn about the side effects of KHK2866 alone or given in combination with chemotherapy All subjects will receive study therapy for up to 6 cycles up to 12 cycles for subjects assigned to PLD Arm 3 of Phase 1b or until disease progression the development of severe side effects noncompliance or withdrawal of consent by the subject or other removal criteria whichever comes first
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