Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645236
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-12-20
Brief Title:
DHF-20-1839-2 Clinical Performance Study Protocol for Therascreen KRAS RGQ PCR Kit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interventional IVD Study Testing DNA from Tumor Tissue Biopsies from MCRC Patients to Determine KRAS G12C Mutation Status for the Inclusion in the Amgen Clinical Trial 20210081 for the Clinical Performance of Therascreen KRAS RGQ PCR Kit
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To utilize the therascreen KRAS RGQ PCR Kit as a screening test in Amgens Phase 3 Clinical Study Protocol 20210081 in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen KRAS RGQ PCR Kit as a companion diagnostic CDx for the identification of patients with metastatic colorectal cancer who may benefit from treatment with sotorasib
Detailed Description:
The proposed device clinical performance study and the medicinal clinical trial will be conducted simultaneously as a combined trial according to MDCG 2022-10 The clinical trial 20210081 is a Randomized Open-label Active-controlled Study of Sotorasib Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects with Metastatic Colorectal Cancer with KRAS pG12C Mutation CodeBreaK 301 It is estimated that approximately 450 patients from 31 countries will be enroled based on the presence of tumor KRAS G12C mutation detected using therascreen KRAS RGQ PCR Kit along with other clinical trial inclusion criteria into the Phase III clinical trial Results from the Phase 3 Amgen Study 20210081 will be used to evaluate the clinical performance of therascreen KRAS RGQ PCR Kit as a CDx device for identification of patients with mCRC who may benefit from treatment with sotorasib in treatment-naïve patients with metastatic colorectal cancer
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