Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01450384
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2011-09-30
Brief Title:
Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I Study of Pemetrexed and Sorafenib in Advanced Malignancy
Status:
COMPLETED
Status Verified Date:
2016-02
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 phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors Pemetrexed disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Sorafenib tosylate may also stop the growth of solid tumors by blocking blood flow to the tumor Giving pemetrexed disodium together with sorafenib tosylate may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine doses for the combination of pemetrexed pemetrexed disodium with sorafenib sorafenib tosylate appropriate for Phase II study
SECONDARY OBJECTIVES
I To evaluate the safety tolerance and toxicity of the combination of pemetrexed and sorafenib
II To observe antitumor effects of the combination
OUTLINE This is a dose-escalation study of pemetrexed disodium and sorafenib tosylate
Patients receive pemetrexed disodium intravenously IV on day 1 every 2 weeks and sorafenib tosylate orally PO twice daily BID on days 1-5 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
I To determine doses for the combination of pemetrexed pemetrexed disodium with sorafenib sorafenib tosylate appropriate for Phase II study
SECONDARY OBJECTIVES
I To evaluate the safety tolerance and toxicity of the combination of pemetrexed and sorafenib
II To observe antitumor effects of the combination
OUTLINE This is a dose-escalation study of pemetrexed disodium and sorafenib tosylate
Patients receive pemetrexed disodium intravenously IV on day 1 every 2 weeks and sorafenib tosylate orally PO twice daily BID on days 1-5 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
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 |
|---|---|---|---|
| P30CA016059 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA016059 |
| NCI-2011-03035 | REGISTRY | None | None |