Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091299
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2004-09-07
Brief Title:
Warfarin and Vatalanib in Treating Patients With Advanced Solid Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
An Open Label Non Randomized One Sequence Add-On Study to Investigate the Effects of PTK787ZK 222584 on the Pharmacokinetics and Pharmacodynamics of Warfarin at Steady-States in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RATIONALE Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor Warfarin may be effective in preventing the formation of blood clots in patients who are undergoing treatment for advanced solid tumors
PURPOSE This phase I trial is studying how well giving warfarin together with vatalanib works in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying how well giving warfarin together with vatalanib works in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the acute and chronic changes in INR in patients with advanced solid tumors treated with low-dose warfarin and vatalanib
Secondary
Determine the steady-state pharmacokinetics of this regimen in these patients
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a nonrandomized open-label multicenter study
Pharmacokinetic PK phase Patients receive oral low-dose warfarin once daily on days 1-14 and oral vatalanib once daily 1 hour before warfarin administration on days 2-14 in the absence of disease progression or unacceptable toxicity
Continuation phase Patients not experiencing a drug interaction in the PK phase continue to receive oral vatalanib and oral low-dose warfarin once daily Patients experiencing a drug interaction INR 20 in the PK phase receive oral vatalanib alone once daily Continuation therapy continues indefinitely in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the acute and chronic changes in INR in patients with advanced solid tumors treated with low-dose warfarin and vatalanib
Secondary
Determine the steady-state pharmacokinetics of this regimen in these patients
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a nonrandomized open-label multicenter study
Pharmacokinetic PK phase Patients receive oral low-dose warfarin once daily on days 1-14 and oral vatalanib once daily 1 hour before warfarin administration on days 2-14 in the absence of disease progression or unacceptable toxicity
Continuation phase Patients not experiencing a drug interaction in the PK phase continue to receive oral vatalanib and oral low-dose warfarin once daily Patients experiencing a drug interaction INR 20 in the PK phase receive oral vatalanib alone once daily Continuation therapy continues indefinitely in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| NOVARTIS-CPTK7870113 | None | None | None |
| UCLA-0403067-01 | None | None | None |