Ignite Creation Date:
2024-05-05 @ 11:04 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01244438
Status:
WITHDRAWN
Last Update Posted:
2021-12-13
First Post:
2010-11-17
Brief Title:
Study of FP-1039 in Subjects With Endometrial Cancers
Sponsor:
Five Prime Therapeutics Inc
Organization:
Five Prime Therapeutics Inc
Study Overview
Official Title:
An Open-Label Phase 2 Pilot Study Evaluating the Activity and Safety of FP 1039 in Subjects With Advanced andor Recurrent Endometrial Cancers With Specific FGFR2 Mutations
Status:
WITHDRAWN
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study FP1039-002 was not feasible The original assumption was at least 5 of patients screened would qualify but after screening 70 patients none qualified
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label non-randomized single arm study to assess the safety tolerability and pharmacokinetics of FP-1039 given by weekly intravenous IV administrations in advanced endometrial cancer patients with FGFR2-specific mutations FP-1039 will be dosed weekly starting at a dose of up to 16 mgkg
Detailed Description:
FP-1039 will be administered intravenously over 30 minutes once a week All enrolled subjects will be monitored for the occurrence of unacceptable toxicity Subjects with no evidence of disease progression or unacceptable toxicity after 4 doses of FP-1039 may continue to receive weekly treatment provided there continues to be no evidence of disease progression or unacceptable toxicity Dosing will be discontinued if a subject has evidence of disease progression Disease will be assessed approximately every 2 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-024344-15 | EUDRACT_NUMBER | None | None |