Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535713
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2020-08-27
Brief Title:
GALLANT Metronomic Gemcitabine Doxorubicin Docetaxel and Nivolumab for Advanced Sarcoma
Sponsor:
Sarcoma Oncology Research Center LLC
Organization:
Sarcoma Oncology Research Center LLC
Study Overview
Official Title:
GALLANT A Phase 2 Study Using Metronomic Gemcitabine Doxorubicin Docetaxel and Nivolumab as SecondThird Line Therapy for Advanced Sarcoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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 is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine doxorubicin and docetaxel and nivolumab immunotherapy given intravenously
Detailed Description:
This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine doxorubicin and docetaxel and nivolumab immunotherapy given intravenously
A total of 260 patients will receive gemcitabine 600 mgm2 maximum dose 1000 mg on D1 and D8 doxorubicin 18 mgm2 on D1 and D8 maximum dose 32 mg docetaxel 25 mgm2 on D1 and D8 maximum dose 42 mg on Days 1 and 8 After the first cycle nivolumab 240 mg IV will be added on Day 1 of each cycle see product information wwwaccessdatafdagov Treatment cycles are given every 3 weeks Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy
A total of 260 patients will receive gemcitabine 600 mgm2 maximum dose 1000 mg on D1 and D8 doxorubicin 18 mgm2 on D1 and D8 maximum dose 32 mg docetaxel 25 mgm2 on D1 and D8 maximum dose 42 mg on Days 1 and 8 After the first cycle nivolumab 240 mg IV will be added on Day 1 of each cycle see product information wwwaccessdatafdagov Treatment cycles are given every 3 weeks Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None