Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
24/06/2021
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
Local Institution - 010-005 - Bedford Park
Recruitment hospital [2] 0 0
Local Institution - 010-004 - Clayton
Recruitment hospital [3] 0 0
Local Institution - 010-006 - Garran
Recruitment hospital [4] 0 0
Local Institution - 010-015 - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - 010-012 - Melbourne
Recruitment hospital [6] 0 0
Local Institution - 010-002 - 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
West Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Caba
Country [36] 0 0
Argentina
State/province [36] 0 0
La Rioja
Country [37] 0 0
Argentina
State/province [37] 0 0
Porto Alegre
Country [38] 0 0
Argentina
State/province [38] 0 0
Viedma
Country [39] 0 0
Austria
State/province [39] 0 0
Innsbruck
Country [40] 0 0
Austria
State/province [40] 0 0
Wiener Neustadt
Country [41] 0 0
Austria
State/province [41] 0 0
Wien
Country [42] 0 0
Belgium
State/province [42] 0 0
Brussel
Country [43] 0 0
Belgium
State/province [43] 0 0
Edegem
Country [44] 0 0
Belgium
State/province [44] 0 0
Gent
Country [45] 0 0
Belgium
State/province [45] 0 0
Yvoir
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio Grande Do Sul
Country [47] 0 0
Brazil
State/province [47] 0 0
Santa Catarina
Country [48] 0 0
Brazil
State/province [48] 0 0
Curitiba
Country [49] 0 0
Brazil
State/province [49] 0 0
Liberdade
Country [50] 0 0
Brazil
State/province [50] 0 0
Santo Andre
Country [51] 0 0
Brazil
State/province [51] 0 0
Sao Jose do Rio Preto
Country [52] 0 0
Brazil
State/province [52] 0 0
Sao Paolo
Country [53] 0 0
Brazil
State/province [53] 0 0
Sao Paulo
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec
Country [56] 0 0
Colombia
State/province [56] 0 0
Barranquilla
Country [57] 0 0
Colombia
State/province [57] 0 0
Bogota
Country [58] 0 0
Colombia
State/province [58] 0 0
Floridablanca
Country [59] 0 0
Colombia
State/province [59] 0 0
Medellin
Country [60] 0 0
Czechia
State/province [60] 0 0
Brno
Country [61] 0 0
Czechia
State/province [61] 0 0
Olomouc
Country [62] 0 0
Czechia
State/province [62] 0 0
Praha 5
Country [63] 0 0
Denmark
State/province [63] 0 0
Copenhagen
Country [64] 0 0
Denmark
State/province [64] 0 0
Odense
Country [65] 0 0
Denmark
State/province [65] 0 0
Vejle
Country [66] 0 0
Finland
State/province [66] 0 0
Helsinki
Country [67] 0 0
Finland
State/province [67] 0 0
Tampere
Country [68] 0 0
Finland
State/province [68] 0 0
Turku
Country [69] 0 0
France
State/province [69] 0 0
Centre-Val De Loire
Country [70] 0 0
France
State/province [70] 0 0
Avignon Cedex 9
Country [71] 0 0
France
State/province [71] 0 0
Besancon
Country [72] 0 0
France
State/province [72] 0 0
Bordeaux
Country [73] 0 0
France
State/province [73] 0 0
Brest
Country [74] 0 0
France
State/province [74] 0 0
Dijon cedex
Country [75] 0 0
France
State/province [75] 0 0
Lille
Country [76] 0 0
France
State/province [76] 0 0
Lyon
Country [77] 0 0
France
State/province [77] 0 0
Marseille Cedex 5
Country [78] 0 0
France
State/province [78] 0 0
Paris Cedex 12
Country [79] 0 0
France
State/province [79] 0 0
Paris
Country [80] 0 0
France
State/province [80] 0 0
Pessac
Country [81] 0 0
France
State/province [81] 0 0
Suresnes
Country [82] 0 0
France
State/province [82] 0 0
Toulouse cedex 9
Country [83] 0 0
France
State/province [83] 0 0
Tours Cedex 9
Country [84] 0 0
France
State/province [84] 0 0
Villejuif
Country [85] 0 0
Germany
State/province [85] 0 0
Amberg
Country [86] 0 0
Germany
State/province [86] 0 0
Berlin
Country [87] 0 0
Germany
State/province [87] 0 0
Bochum
Country [88] 0 0
Germany
State/province [88] 0 0
Dresden
Country [89] 0 0
Germany
State/province [89] 0 0
Frankfurt am Main
Country [90] 0 0
Germany
State/province [90] 0 0
Hamburg
Country [91] 0 0
Germany
State/province [91] 0 0
Herne
Country [92] 0 0
Germany
State/province [92] 0 0
Monchengladbach
Country [93] 0 0
Germany
State/province [93] 0 0
Munchen
Country [94] 0 0
Germany
State/province [94] 0 0
Reutlingen
Country [95] 0 0
Germany
State/province [95] 0 0
Ulm
Country [96] 0 0
Greece
State/province [96] 0 0
Athens
Country [97] 0 0
Greece
State/province [97] 0 0
Cholargos
Country [98] 0 0
Greece
State/province [98] 0 0
Heraklion
Country [99] 0 0
Greece
State/province [99] 0 0
Larissa
Country [100] 0 0
Greece
State/province [100] 0 0
Thessaloniki
Country [101] 0 0
Hong Kong
State/province [101] 0 0
Central
Country [102] 0 0
Hong Kong
State/province [102] 0 0
Hong Kong
Country [103] 0 0
Ireland
State/province [103] 0 0
Dublin
Country [104] 0 0
Italy
State/province [104] 0 0
Avellino
Country [105] 0 0
Italy
State/province [105] 0 0
Biella
Country [106] 0 0
Italy
State/province [106] 0 0
Cagliari
Country [107] 0 0
Italy
State/province [107] 0 0
Candiolo
Country [108] 0 0
Italy
State/province [108] 0 0
Lido di Camaiore
Country [109] 0 0
Italy
State/province [109] 0 0
Meldola
Country [110] 0 0
Italy
State/province [110] 0 0
Milano
Country [111] 0 0
Italy
State/province [111] 0 0
Milan
Country [112] 0 0
Italy
State/province [112] 0 0
Napoli
Country [113] 0 0
Italy
State/province [113] 0 0
Padova
Country [114] 0 0
Italy
State/province [114] 0 0
Pisa
Country [115] 0 0
Italy
State/province [115] 0 0
Reggio Emilia
Country [116] 0 0
Italy
State/province [116] 0 0
Roma
Country [117] 0 0
Italy
State/province [117] 0 0
Torino
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Anyang-si
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Busan
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Daejeon
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Goyang-si
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Hwasun-gun
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Seongnam-si
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Seoul
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Suwon-Si
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Yangsan-si
Country [127] 0 0
Malaysia
State/province [127] 0 0
Johor
Country [128] 0 0
Malaysia
State/province [128] 0 0
Sabah
Country [129] 0 0
Malaysia
State/province [129] 0 0
Selangor
Country [130] 0 0
Malaysia
State/province [130] 0 0
Kuala Lumpur
Country [131] 0 0
Malaysia
State/province [131] 0 0
Putrajaya
Country [132] 0 0
Mexico
State/province [132] 0 0
Chiapas
Country [133] 0 0
Mexico
State/province [133] 0 0
Distrito Federal
Country [134] 0 0
Mexico
State/province [134] 0 0
Jalisco
Country [135] 0 0
Mexico
State/province [135] 0 0
Morelos
Country [136] 0 0
Mexico
State/province [136] 0 0
Queretaro
Country [137] 0 0
Mexico
State/province [137] 0 0
Veracruz
Country [138] 0 0
Netherlands
State/province [138] 0 0
Amsterdam
Country [139] 0 0
Netherlands
State/province [139] 0 0
Nijmegen
Country [140] 0 0
Netherlands
State/province [140] 0 0
Utrecht
Country [141] 0 0
Poland
State/province [141] 0 0
Gdansk
Country [142] 0 0
Poland
State/province [142] 0 0
Otwock
Country [143] 0 0
Poland
State/province [143] 0 0
Warszawa
Country [144] 0 0
Portugal
State/province [144] 0 0
Braga
Country [145] 0 0
Portugal
State/province [145] 0 0
Lisbon
Country [146] 0 0
Portugal
State/province [146] 0 0
Porto
Country [147] 0 0
Puerto Rico
State/province [147] 0 0
San Juan
Country [148] 0 0
Romania
State/province [148] 0 0
Baia Mare
Country [149] 0 0
Romania
State/province [149] 0 0
Brasov
Country [150] 0 0
Romania
State/province [150] 0 0
Bucharest
Country [151] 0 0
Romania
State/province [151] 0 0
Cluj-Napoca
Country [152] 0 0
Romania
State/province [152] 0 0
Craiova
Country [153] 0 0
Romania
State/province [153] 0 0
Ovidiu
Country [154] 0 0
Romania
State/province [154] 0 0
Timisoara
Country [155] 0 0
Singapore
State/province [155] 0 0
Singapore
Country [156] 0 0
Spain
State/province [156] 0 0
A Coruna
Country [157] 0 0
Spain
State/province [157] 0 0
Badalona
Country [158] 0 0
Spain
State/province [158] 0 0
Barcelona
Country [159] 0 0
Spain
State/province [159] 0 0
Cordoba
Country [160] 0 0
Spain
State/province [160] 0 0
LHospitalet de Llobregat
Country [161] 0 0
Spain
State/province [161] 0 0
Madrid
Country [162] 0 0
Spain
State/province [162] 0 0
Pamplona
Country [163] 0 0
Spain
State/province [163] 0 0
Sabadell
Country [164] 0 0
Spain
State/province [164] 0 0
Santander
Country [165] 0 0
Spain
State/province [165] 0 0
Valencia
Country [166] 0 0
Taiwan
State/province [166] 0 0
Changhua City
Country [167] 0 0
Taiwan
State/province [167] 0 0
Kaohsiung
Country [168] 0 0
Taiwan
State/province [168] 0 0
Taichung
Country [169] 0 0
Taiwan
State/province [169] 0 0
Tainan City
Country [170] 0 0
Taiwan
State/province [170] 0 0
Tainan
Country [171] 0 0
Taiwan
State/province [171] 0 0
Taipei City
Country [172] 0 0
Taiwan
State/province [172] 0 0
Taoyuan
Country [173] 0 0
Thailand
State/province [173] 0 0
Bang Phlat
Country [174] 0 0
Thailand
State/province [174] 0 0
Bangkok
Country [175] 0 0
Thailand
State/province [175] 0 0
Chiang Mai
Country [176] 0 0
Thailand
State/province [176] 0 0
Hat Yai
Country [177] 0 0
Thailand
State/province [177] 0 0
Khlong Toey
Country [178] 0 0
Ukraine
State/province [178] 0 0
Sumy
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Aberdeen
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Birmingham
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Cambridge
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Dorset
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Glasgow
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Kent
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Leeds
Country [186] 0 0
United Kingdom
State/province [186] 0 0
London
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Manchester
Country [188] 0 0
United Kingdom
State/province [188] 0 0
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