Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244972
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2005-10-25
Brief Title:
Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Tipifarnib R115777 and Sorafenib BAY 43-9006 in Patients With Biopsiable Advanced Cancers
Status:
COMPLETED
Status Verified Date:
2017-04
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 tipifarnib when given together with sorafenib tosylate in treating patients with biopsiable cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment Tipifarnib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and toxicity and to determine maximum tolerated dose MTD of tipifarnib in combination with sorafenib sorafenib tosylate
SECONDARY OBJECTIVES
I Preliminary assessment of tipifarnib and sorafenib efficacy objective response
II To determine signaling pathway profiles of patients treated with tipifarnib and sorafenib who are amenable to biopsy by reverse phase protein microarray RPPA analysis
OUTLINE This is a dose-escalation study of tipifarnib
Patients receive sorafenib tosylate orally PO once daily QD or twice daily BID on days 1-28 and tipifarnib PO QD or BID on days 1-21 Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity Patients may be allowed to continue the treatment after the 12 courses if there is continued clinical response or disease stabilization and patients do not have significant toxicities
After completion of study treatment patients are followed up for 4 weeks
I To evaluate the safety and toxicity and to determine maximum tolerated dose MTD of tipifarnib in combination with sorafenib sorafenib tosylate
SECONDARY OBJECTIVES
I Preliminary assessment of tipifarnib and sorafenib efficacy objective response
II To determine signaling pathway profiles of patients treated with tipifarnib and sorafenib who are amenable to biopsy by reverse phase protein microarray RPPA analysis
OUTLINE This is a dose-escalation study of tipifarnib
Patients receive sorafenib tosylate orally PO once daily QD or twice daily BID on days 1-28 and tipifarnib PO QD or BID on days 1-21 Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity Patients may be allowed to continue the treatment after the 12 courses if there is continued clinical response or disease stabilization and patients do not have significant toxicities
After completion of study treatment patients are followed up for 4 weeks
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 |
|---|---|---|---|
| U01CA062461 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062461 |
| NCI-2009-00132 | REGISTRY | None | None |
| 2005-0363 | None | None | None |
| CDR0000446569 | None | None | None |
| 2005-0363 | OTHER | None | None |
| 7156 | OTHER | None | None |
| P30CA016672 | NIH | None | None |