Advanced Colorectal Cancer with KRAS G12C Mutation MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Adagrasib
Product Code: MRTX849
Pharmaceutical Form: Tablet
INN or Proposed INN: Adagrasib
CAS Number: 2326521-71-3
Current Sponsor code: MRTX849
Other descriptive name: Adagrasib
Concen
Sponsors
Mirati Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 210
Exclusion criteria
Exclusion criteria: - Prior treatment with both an oxaliplatin-and irinotecan-based regimen for CRC, concurrently or successively, in any setting (neoadjuvant, adjuvant or advanced). - 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of adagrasib in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation.;Secondary Objective: - To evaluate secondary efficacy endpoints in the study population. - To evaluate the safety and tolerability in the study population. - To evaluate the pharmacokinetics (PK) of adagrasib administered in combination with cetuximab. - To evaluate health-related quality of life (HRQOL) and cancer-related symptoms in the study population. ;Primary end point(s): - Overall Survival (OS) - Progression-free Survival (PFS);Timepoint(s) of evaluation of this end point: 30 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse Events - Objective Response Rate (ORR) - Duration of Response (DOR) - Patient Reported Outcomes (PROs) - Quality of Life Assessment ;Timepoint(s) of evaluation of this end point: 30 Months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactMirati Study Locator Services
Mirati Therapeutics, Inc.
Outcome results
None listed