Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400569
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2006-11-15
Brief Title:
Phase II Study of Sunitinib Malate for Metastatic andor Surgically Unresectable Soft Tissue Sarcoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Open-Label Study of Sunitinib Malate SU011248 in Adult Patients With Metastatic andor Surgically Unresectable Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-07
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 single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle Treatment will be continued until there is either disease progression or cumulativeacute toxicity
All patients with unresectable or metastatic soft tissue sarcoma STS leiomyosarcoma liposarcoma fibrosarcoma and malignant fibrous histiocytoma MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study
All patients with unresectable or metastatic soft tissue sarcoma STS leiomyosarcoma liposarcoma fibrosarcoma and malignant fibrous histiocytoma MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study
Detailed Description:
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate an oral multi-kinase inhibitor The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle Treatment will be continued until there is either disease progression or cumulativeacute toxicity which in the opinion of the treating physician or the trial Principal Investigator PI compromises the ability of the patient to receive treatment or the patient desires to stop treatment
All patients with unresectable or metastatic STS leiomyosarcoma liposarcoma fibrosarcoma and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study
An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination Complete blood count CBC and differential comprehensive metabolic panel and electrocardiogram ECG will be obtained at every scheduled visit
All patients with unresectable or metastatic STS leiomyosarcoma liposarcoma fibrosarcoma and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study
An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination Complete blood count CBC and differential comprehensive metabolic panel and electrocardiogram ECG will be obtained at every scheduled visit
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 |
|---|---|---|---|
| GA618075 | OTHER | Pfizer Pharamaceutic | None |