Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358163
Status:
TERMINATED
Last Update Posted:
2022-04-29
First Post:
2006-07-28
Brief Title:
Trial of PTK787ZK 222584 Plus Paclitaxel
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase I Study of the Oral Vascular Endothelial Growth Factor Inhibitor PTK787ZK 222584 in Combination With Paclitaxel in Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2022-04
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:
PTK787ZK 222584 is an inhibitor of VEGFR family tyrosine kinases The primary objective of this study is to assess the safety of daily oral PTK787ZK 222584 in combination with paclitaxel infused every 21 days Secondary objectives include pharmacokinetic assessment of the impact of PTK787ZK 222584 on paclitaxel metabolism and evaluation of tumor response to the investigational treatment
Detailed Description:
We are looking for the highest dose of Paclitaxel that can be given safely in combination with the highest safe dose of Vatalanib Therefore not all people will receive the same dose of the study drug
Small groups of people will be enrolled in steps on this trial This first group will be given a certain dose of Paclitaxel and Vatalanib If they have few or manageable side effects the next small group of people enrolled will receive higher doses of the study drugs This increase in doses will continue until the study doctors find the highest dose of the drugs that can be given without causing severe or unmanageable side effects
In this study Vatalanib tablets are taken daily and paclitaxel is given by three-hour intravenous infusion once every 21 days
Small groups of people will be enrolled in steps on this trial This first group will be given a certain dose of Paclitaxel and Vatalanib If they have few or manageable side effects the next small group of people enrolled will receive higher doses of the study drugs This increase in doses will continue until the study doctors find the highest dose of the drugs that can be given without causing severe or unmanageable side effects
In this study Vatalanib tablets are taken daily and paclitaxel is given by three-hour intravenous infusion once every 21 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