Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02495415
Status:
UNKNOWN
Last Update Posted:
2019-07-23
First Post:
2015-07-07
Brief Title:
Trial of Intravenous Fenretinide Emulsion for Patients With RelapsedRefractory Peripheral T-cell Lymphomas
Sponsor:
CerRx Inc
Organization:
CerRx Inc
Study Overview
Official Title:
Phase II Trial of Intravenous Fenretinide N-4-hydroxyphenyl Retinamide 4-HPR Emulsion for Patients With RelapsedRefractory Peripheral T-cell Lymphomas PTCL
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
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:
This study addresses the hypothesis that intermittent treatment with fenretinide intravenous emulsion will induce objective responses in patients with relapsed or refractory Peripheral T-cell Lymphoma PTCL who have failed at least one prior systemic therapy and will result in acceptable toxicities
Detailed Description:
This is an open-label multicenter single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma who have failed at least one prior system therapy
Approximately 140 patients will be enrolled Patients will be treated with fenretinide 4-HPR intravenous emulsion administered as a continuous intravenous infusion for 5 days once every 3 weeks until there is disease progression or unmanageable treatment-related toxicities
The primary study endpoint is objective response rate ORR Responses will be categorized using criteria established by the International Harmonization Project on Lymphoma Safety will be evaluated during the study and for 30 days after the last administration of study drug Adverse events and laboratory studies will be graded according to NCI-CTCAE v 403
Approximately 140 patients will be enrolled Patients will be treated with fenretinide 4-HPR intravenous emulsion administered as a continuous intravenous infusion for 5 days once every 3 weeks until there is disease progression or unmanageable treatment-related toxicities
The primary study endpoint is objective response rate ORR Responses will be categorized using criteria established by the International Harmonization Project on Lymphoma Safety will be evaluated during the study and for 30 days after the last administration of study drug Adverse events and laboratory studies will be graded according to NCI-CTCAE v 403
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