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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04793958




Registration number
NCT04793958
Ethics application status
Date submitted
2/03/2021
Date registered
11/03/2021

Titles & IDs
Public title
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
Scientific title
A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy
Secondary ID [1] 0 0
KRYSTAL-10
Secondary ID [2] 0 0
CA239-0006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Colorectal Cancer 0 0
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - MRTX849
Treatment: Other - Cetuximab
Treatment: Drugs - mFOLFOX6 Regimen
Treatment: Drugs - FOLFIRI Regimen

Experimental: MRTX849 + Cetuximab -

Active comparator: mFOLFOX6 or FOLFIRI -


Treatment: Drugs: MRTX849
28 Day Cycle

Treatment: Other: Cetuximab
28 Day Cycle

Treatment: Drugs: mFOLFOX6 Regimen
* Fluorouracil
* Oxaliplatin
* Folinic acid

Treatment: Drugs: FOLFIRI Regimen
* Fluorouracil
* Irinotecan
* Folinic acid
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
30 months
Primary outcome [2] 0 0
Progression-free Survival (PFS)
Timepoint [2] 0 0
30 months
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
30 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
30 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
30 months
Secondary outcome [4] 0 0
Patient Reported Outcomes (PROs)
Timepoint [4] 0 0
30 months
Secondary outcome [5] 0 0
Quality of Life Assessment
Timepoint [5] 0 0
30 months

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
* Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
* Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
* Active brain metastasis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
Accrual to date
Final
461
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Canberra Region Cancer Centre - Garran
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
The Alfred - Melbourne
Recruitment hospital [6] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2065 - Garran
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment outside Australia
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Middlesex

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mirati Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04793958