Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281125
Status:
TERMINATED
Last Update Posted:
2012-03-19
First Post:
2006-01-06
Brief Title:
Phase III Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer
Sponsor:
Nevada Cancer Institute
Organization:
Nevada Cancer Institute
Study Overview
Official Title:
A Two-Cohort Phase III Trial of PTK787 and Pemetrexed With or Without Cisplatin in Patients With Advanced Non-Small Cell Lung Cancers and Malignant Pleural Mesotheliomas
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Suspended due to data issues revealed at DSMB meeting Planned amendment but was never submitted Study was then closed
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 two-arm multicenter Phase IAII dose-escalation study of PTK787 in combination with Pemetrexed alone Cohort 1 or Pemetrexed and Cisplatin Cohort 2
This study is designed to determine the maximum tolerated dose MTD and dose limiting toxicity DLT of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin and to characterize the safety tolerability biologic activity and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas
This study is designed to determine the maximum tolerated dose MTD and dose limiting toxicity DLT of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin and to characterize the safety tolerability biologic activity and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas
Detailed Description:
This is an open-label two-arm multicenter Phase IAII dose-escalation study of PTK787 in combination with Pemetrexed alone Cohort 1 or Pemetrexed and Cisplatin Cohort 2
This study is designed to determine the maximum tolerated dose MTD and dose limiting toxicity DLT of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin and to characterize the safety tolerability biologic activity and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas
In cohort 1 PTK787 will be administered orally every 12 hours on days 2-42 of a 42-day cycle In addition Pemetrexed will be administered on days 1 and 22
In cohort 2 PTK787 will be administered orally every 12 hours on days 2-42 of a 42 day cycle In addition Pemetrexed will be administered on days 1 and 22 Thirty minutes after Pemetrexed administration Cisplatin will be infused on days 1 and 22
In the current study initially patients will be treated on Cohort 1 Pemetrexed PTK787 Once an MTD determination is made on this cohort or PTK787 has been escalated to the maximum dose of 750 mg Q12h enrollment will begin on Cohort 2 At the MTD dose both cohorts will be expanded to a minimum of 20 patients to determine additional safety of the combinations
This study is designed to determine the maximum tolerated dose MTD and dose limiting toxicity DLT of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin and to characterize the safety tolerability biologic activity and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas
In cohort 1 PTK787 will be administered orally every 12 hours on days 2-42 of a 42-day cycle In addition Pemetrexed will be administered on days 1 and 22
In cohort 2 PTK787 will be administered orally every 12 hours on days 2-42 of a 42 day cycle In addition Pemetrexed will be administered on days 1 and 22 Thirty minutes after Pemetrexed administration Cisplatin will be infused on days 1 and 22
In the current study initially patients will be treated on Cohort 1 Pemetrexed PTK787 Once an MTD determination is made on this cohort or PTK787 has been escalated to the maximum dose of 750 mg Q12h enrollment will begin on Cohort 2 At the MTD dose both cohorts will be expanded to a minimum of 20 patients to determine additional safety of the combinations
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