Viewing Study NCT01244438



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Status: WITHDRAWN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Status: WITHDRAWN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