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Trial Title:
DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
NCT ID:
NCT06645236
Condition:
Metastatic Colorectal Cancer (mCRC)
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Metastatic Colorectal Cancer
therascreen
KRAS G12C
sotorasib
Clinical Performance Study
Companion Diagnostic
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
therascreen® KRAS RGQ PCR Kit
Description:
The investigational device, therascreen® KRAS RGQ PCR Kit, will be used to determine the
KRAS G12C mutation status of patients during the screening period of Amgen's clinical
trial (20210081)
Arm group label:
Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit
Summary:
To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's 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 p.G12C 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects who consent to participate in the eligibility screen for Protocol 20210081
will have their tumor tissue tested for the presence of KRAS G12C mutation under the
proposed performance study.
Exclusion Criteria:
- There is no separate inclusion and exclusion criteria for the performance study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
QIAGEN Gaithersburg, Inc
Address:
City:
Manchester
Zip:
M130BH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sarah G Johnson
Email:
Sarah.Johnson@qiagen.com
Contact backup:
Last name:
Helen Green
Email:
Helen.Green@qiagen.com
Start date:
December 22, 2023
Completion date:
October 31, 2030
Lead sponsor:
Agency:
QIAGEN Gaithersburg, Inc
Agency class:
Industry
Source:
QIAGEN Gaithersburg, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06645236
