Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284141
Status:
COMPLETED
Last Update Posted:
2012-12-10
First Post:
2006-01-30
Brief Title:
Study of AVE0005 VEGF Trap in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Open-label Single-arm Two-stage Study of the Efficacy and Safety of AVE0005 VEGF Trap Administered Intravenously Every 2 Weeks in Patients With Platinum- and Erlotinib-resistant Locally Advanced or Metastatic Non-small-cell Lung Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2011-07
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 study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma NSCLA
Primary objective
To determine the overall objective response rate ORR of AVE0005 ziv-aflibercept aflibercept VEGF trap ZALTRAP 40 mgkg intravenously IV every 2 weeks in participants with platinum- and erlotinib-resistant locally advanced or metastatic NSCLA
Secondary objective
To assess duration of response DR progression-free survival PFS and overall survival OS in this participant population
To evaluate the safety profile of IV AVE0005 ziv-aflibercept aflibercept VEGF trap ZALTRAP
This study employed an Independent Review Committee IRC for radiological tumor assessments For all tumor assessment-related efficacy variables two analyses were performed the primary analysis was based on Independent Review Committee IRC reviewed data and the secondary analysis was based on Investigator evaluation
In addition both Response Evaluation Criteria In Solid Tumors RECIST and Modified Response Evaluation Criteria In Solid Tumors mRECIST were used to assess tumors Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer NSCLC Responses based on RECIST and mRECIST are reported
Primary objective
To determine the overall objective response rate ORR of AVE0005 ziv-aflibercept aflibercept VEGF trap ZALTRAP 40 mgkg intravenously IV every 2 weeks in participants with platinum- and erlotinib-resistant locally advanced or metastatic NSCLA
Secondary objective
To assess duration of response DR progression-free survival PFS and overall survival OS in this participant population
To evaluate the safety profile of IV AVE0005 ziv-aflibercept aflibercept VEGF trap ZALTRAP
This study employed an Independent Review Committee IRC for radiological tumor assessments For all tumor assessment-related efficacy variables two analyses were performed the primary analysis was based on Independent Review Committee IRC reviewed data and the secondary analysis was based on Investigator evaluation
In addition both Response Evaluation Criteria In Solid Tumors RECIST and Modified Response Evaluation Criteria In Solid Tumors mRECIST were used to assess tumors Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer NSCLC Responses based on RECIST and mRECIST are reported
Detailed Description:
The study included
A screening phase up to 21 days followed by registration
Treatment initiation within 5 working days of registration
A treatment phase with 14-day study treatment cycles until a study withdrawal criterion was met or up to the clinical database cut-off date 18 July 2008
A follow-up phase - up to 60 days after end of treatment
Withdrawal criteria that led to treatment discontinuation were
The participant or their legally authorized representative requested to withdraw
In the investigators opinion continuation of the study would be detrimental to the participants well being due to reasons such as disease progression unacceptable toxicity noncompliance or logistical considerations
A specific request by the Sponsor
Participant had intercurrent illness that prevented further administration of study treatment
Participant had more than 2 aflibercept dose reductions
Participant had arterial thromboembolic events including cerebrovascular accidents myocardial infarctions transient ischemic attacks new onset or worsening of pre-existing angina
Participant had radiographic evidence of intestinal obstruction eg dilated loops of bowel accompanied by air-fluid levels or gastrointestinal perforation eg presence of extraluminal gas requiring surgical intervention
Participant was lost to follow-up
After discontinuing treatment participants remained on the study until the last post-treatment visit or until recovery of drug related toxicities whichever was later
A screening phase up to 21 days followed by registration
Treatment initiation within 5 working days of registration
A treatment phase with 14-day study treatment cycles until a study withdrawal criterion was met or up to the clinical database cut-off date 18 July 2008
A follow-up phase - up to 60 days after end of treatment
Withdrawal criteria that led to treatment discontinuation were
The participant or their legally authorized representative requested to withdraw
In the investigators opinion continuation of the study would be detrimental to the participants well being due to reasons such as disease progression unacceptable toxicity noncompliance or logistical considerations
A specific request by the Sponsor
Participant had intercurrent illness that prevented further administration of study treatment
Participant had more than 2 aflibercept dose reductions
Participant had arterial thromboembolic events including cerebrovascular accidents myocardial infarctions transient ischemic attacks new onset or worsening of pre-existing angina
Participant had radiographic evidence of intestinal obstruction eg dilated loops of bowel accompanied by air-fluid levels or gastrointestinal perforation eg presence of extraluminal gas requiring surgical intervention
Participant was lost to follow-up
After discontinuing treatment participants remained on the study until the last post-treatment visit or until recovery of drug related toxicities whichever was later
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 |
|---|---|---|---|
| AVE0005B2001 | None | None | None |