Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094835
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2004-10-27
Brief Title:
Study to Evaluate Motesanib With or Without CarboplatinPaclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-label Dose-finding Study to Evaluate the Safety and Pharmacokinetics PK of AMG 706 With CarboplatinPaclitaxel AMG 706 With Panitumumab and AMG 706 With Panitumumab and CarboplatinPaclitaxel in the Treatment of Subjects With Advanced Non-Small Cell Lung Cancer NSCLC
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:
The purpose of this trial is - To characterize the safety profile of motesanib when used in combination with carboplatinpaclitaxel CP with panitumumab or with CP and panitumumab in patients with advanced non-small cell lung cancer NSCLC - To establish the pharmacokinetic PK profile of motesanib when it is used in combination with CP with panitumumab or with CP and panitumumab - To compare the paclitaxel and motesanib PK profiles when the medications are administered 30 minutes min or approximately 48 hours hrs apart - To characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with CP motesanib with panitumumab or motesanib with CP and panitumumab - To describe the objective response rate ORR in each dose cohort - To measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with CP and panitumumab
Detailed Description:
This was a multicenter open-label dose-finding clinical trial examining the safety and PK of once or twice daily motesanib administered with CP or with CP and panitumumab in chemotherapy naïve patients and with panitumumab in patients with no more than one prior chemotherapy regimen for NSCLC
Participants were enrolled into the Panitumumab Paclitaxel Carboplatin Motesanib once a safe and tolerable dose of AMG 706 was established in the other treatment arms
Participants were enrolled into the Panitumumab Paclitaxel Carboplatin Motesanib once a safe and tolerable dose of AMG 706 was established in the other treatment arms
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