Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787341
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2021-02-24
Brief Title:
PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence
Sponsor:
Gruppo Oncologico del Nord-Ovest
Organization:
Gruppo Oncologico del Nord-Ovest
Study Overview
Official Title:
Randomized Phase II Study of Panitumumab Rechallenge Followed by Regorafenib Versus the Reverse Sequence in RAS and BRAF Wild-type Chemorefractory Mestastatic Colorectal Cancer Patients
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PARERE
Brief Summary:
The association of doublet chemotherapy FOLFOX and FOLFIRI and anti-EGFR-moAbs panitumumab or cetuximab is a standard option for the first-line treatment of unresectable RAS and BRAF wt mCRC patients especially with left-sided primary tumour
In RAS wt mCRC patients refractory to chemotherapy and anti-EGFR naive the standard treatment sequence is an anti-EGFR-based therapy panitumumab or cetuximab - irinotecan followed by regorafenib
In a phase II randomized Japanese study named REVERCE a higher OS was reported in favour of an experimental strategy of regorafenib followed at progression by cetuximab - irinotecan compared with the reverse standard sequence in chemorefractory and anti-EGFR-naïve RAS wt mCRC patients
However the limitations of the REVERCE study phase II trial with a premature conclusion for poor accrual do not allow us to draw definitive conclusions In addition nowadays patients candidates to an anti-EGFR-based treatment receive anti-EGFRMoAbs in earlier lines of therapy thus affecting the translation of these results in the current clinical practice
Retrospective analyses and a phase II single-arm trial showed promising activity of anti-EGFR rechallenge in patients who previously achieved benefit from a first-line anti- EGFR-based treatment and not bearing RAS mutation on ct-DNA at the rechallenge baseline
Based on these considerations the Investigators designed the present phase II randomized study of panitumumab followed at progression by regorafenib versus the reverse sequence in RAS and BRAF wt mCRC patients with the following characteristics
1 previous treatment with or not considered candidates for fluoropyrimidine oxaliplatin irinotecan and an anti-angiogenic agent bevacizumab or aflibercept
2 RECIST response or stable disease lasting at least 6 months to a previous first-line anti-EGFR-based treatment
3 RAS and BRAF wt ct-DNA at the time of screening The aim of this study is to compare the two sequences in a Caucasian population of patients candidates to anti-EGFR rechallenge
In RAS wt mCRC patients refractory to chemotherapy and anti-EGFR naive the standard treatment sequence is an anti-EGFR-based therapy panitumumab or cetuximab - irinotecan followed by regorafenib
In a phase II randomized Japanese study named REVERCE a higher OS was reported in favour of an experimental strategy of regorafenib followed at progression by cetuximab - irinotecan compared with the reverse standard sequence in chemorefractory and anti-EGFR-naïve RAS wt mCRC patients
However the limitations of the REVERCE study phase II trial with a premature conclusion for poor accrual do not allow us to draw definitive conclusions In addition nowadays patients candidates to an anti-EGFR-based treatment receive anti-EGFRMoAbs in earlier lines of therapy thus affecting the translation of these results in the current clinical practice
Retrospective analyses and a phase II single-arm trial showed promising activity of anti-EGFR rechallenge in patients who previously achieved benefit from a first-line anti- EGFR-based treatment and not bearing RAS mutation on ct-DNA at the rechallenge baseline
Based on these considerations the Investigators designed the present phase II randomized study of panitumumab followed at progression by regorafenib versus the reverse sequence in RAS and BRAF wt mCRC patients with the following characteristics
1 previous treatment with or not considered candidates for fluoropyrimidine oxaliplatin irinotecan and an anti-angiogenic agent bevacizumab or aflibercept
2 RECIST response or stable disease lasting at least 6 months to a previous first-line anti-EGFR-based treatment
3 RAS and BRAF wt ct-DNA at the time of screening The aim of this study is to compare the two sequences in a Caucasian population of patients candidates to anti-EGFR rechallenge
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None