Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418938
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2007-01-04
Brief Title:
SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Multi-center Open-label Randomized Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI With Either Panitumumab or Bevacizumab as Second-Line Treatment in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Tumors
Status:
COMPLETED
Status Verified Date:
2018-09
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 is a multi-center open-label randomized phase 2 two-arm clinical trial to be conducted in the United States Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy with at least 4 doses of oxaliplatin-based chemotherapy with at least 4 doses of bevacizumab failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment will be randomized in a 11 ratio to receive either a once-every-two-weeks Q2W FOLFIRI regimen plus panitumumab 6 mgkg or a Q2W FOLFIRI regimen plus bevacizumab either 5 mgkg or 10 mgkg depending on physician choice and institutional standard of care
Detailed Description:
This phase 2 multicenter open-label randomized two-arm study was designed to estimate the treatment effect of panitumumab in combination with FOLFIRI compared to bevacizumab in combination with FOLFIRI in subjects with metastatic colorectal cancer mCRC who had failed first-line therapy with at least 4 doses of oxaliplatin-based chemotherapy and bevacizumab After data became available demonstrating that the treatment effect of antiepidermal growth factor receptor EGFR agents was limited to patients with wild-type Kirsten rat Sarcoma-2 virus KRAS mCRC the study was amended to enroll only subjects with wild-type KRAS tumors Eligible subjects were randomized in a 11 ratio to receive panitumumab 6 mgkg plus FOLFIRI once every 2 weeks Q2W or bevacizumab 5 mgkg or 10 mgkg plus FOLFIRI Q2W Randomization was stratified by the reason for first-line treatment failure progression vs toxicity and by intended bevacizumab dose 5 mgkg vs 10 mgkg The intended bevacizumab doses were ascertained from sites at the time of site initiation Subjects were treated with all or any components of second-line treatment until the occurrence of unacceptable adverse events disease progression death loss to follow up or study withdrawal by the subject investigator or sponsor Tumor response was evaluated by blinded central radiology review per modified Response Evaluation Criteria in Solid Tumors RECIST version 10 and by the investigator using either modified RECIST version 10 or clinical assessment After subjects permanently discontinued all components of second-line treatment they were to undergo a safety follow-up assessment 30 7 days after the last dose Subjects ending second-line treatment before disease progression were followed for PFS radiographic disease assessment every 12 weeks 14 days from the safety follow-up visit until disease progression initiation of a new therapy for mCRC or until approximately 100 PFS events were observed in subjects with wild-type KRAS tumors Subjects were also followed for survival every 12 weeks 14 days from the safety follow-up assessment until approximately 100 PFS events were observed in subjects with wild-type KRAS tumors
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