Study of the investigational drug MEHD7945A compared to the anticancer drug cetuximab when combined with standard chemotherapy in patients with colorectal cancer without mutation in the KRAS gene (Kras wild type).

Phase 1

• Conditions: Colorectal cancer that does not carry mutation in the KRAS gene; MedDRA version: 20.0 Level: PT Classification code 10001167 Term: Adenocarcinoma of colon System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10038019 Term: Rectal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005547-27-GB
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-31
• Study Completion: 2014-11-26
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 134

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum cancer with wildtype Kras status
•Progressive disease on or after a first-line oxaliplatin-containing chemotherapy regimen for mCRC
•Availability and willingness to provide archival tumor tissue for biomarker testing
•Age =18 years
•Male and female
•Life expectancy =12 weeks
•ECOG 0 or 1
•Disease that is measurable per RECIST v1.1
•Adequate hematologic and end-organ function

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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Prior treatment with irinotecan
•Prior treatment with an investigational or approved HER-targeted agent
•Last anti tumor therapy within 4 weeks prior to Day 1 of the study treatment with exception of oxaliplatin-containing chemotherapy and palliative radiotherapy
•Leptomeningeal disease as the only manifestation of the current malignancy
•Major surgical procedure within 4 weeks prior to Day 1 of the study treatment
•Current severe, uncontrolled systemic disease
•History of cardiac heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment
•History of myocardial infarction within 6 months prior to Day 1 of the study treatment, or history of unstable angina
•Clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; or current alcohol abuse
•Clinically significant gastrointestinal bleeding within 6 months prior to Day 1 of the study treatment
•History of ILD
•History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy
•Untreated or progressing CNS metastases
•Women during pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified