Phase
Condition
Colon Cancer
Colon Cancer; Rectal Cancer
Colorectal Cancer
Treatment
M9140
Folinic acid
Capecitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with documented histopathological diagnosis of locally advanced ormetastatic colorectal cancer (CRC), who were intolerant/refractory to or progressedafter standard systemic therapies for the advanced/metastatic stage, if locallyindicated and available to the participant. Participants with a known microsatelliteinstability high (MSI-H) status must have received treatment with an immunecheckpoint inhibitor (if locally indicated and available) unless contraindicated.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
Participants with adequate hematologic, hepatic and renal function as defined inprotocol
Other protocol defined inclusion criteria could apply
Exclusion
Exclusion Criteria:
Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situof the cervix, benign prostate neoplasm/hypertropia, or malignancy that in theopinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, isconsidered cured with minimal risk of recurrence within 3 years)
Participants with known brain metastases, except those meeting the followingcriteria: Brain metastases that have been treated locally and are clinically stablefor at least 4 weeks prior to the start of treatment; No ongoing neurologicalsymptoms that are related to the brain localization of the disease (sequelae thatare a consequence of the treatment of the brain metastases are acceptable)
Participants with diarrhea (liquid stool) or ileus Grade > 1
Participants with active chronic inflammatory bowel disease (e.g., ulcerativecolitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
Unstable angina, myocardial infarction, congestive heart failure (New York HeartAssociation [NYHA] >= II) or a coronary revascularization procedure within 180 daysof study entry. Calculated QTc average (using the Fridericia correction calculation)of > 470 milliseconds (ms)
Cerebrovascular accident/stroke (< 6 months prior to enrollment)
Other protocol defined exclusion criteria could apply
Study Design
Connect with a study center
The Ottawa Hospital Cancer Centre
Ottawa,
CanadaActive - Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto,
CanadaActive - Recruiting
National Cancer Center Hospital - Dept of Gastroenterology
Chuo-ku,
JapanActive - Recruiting
National Cancer Center Hospital East
Kashiwa-shi,
JapanActive - Recruiting
Saitama Cancer Center
Kitaadachi-gun,
JapanActive - Recruiting
Cancer Institute Hospital of JFCR
Koto-ku,
JapanActive - Recruiting
Aichi Cancer Center Hospital
Nagoya-shi,
JapanActive - Recruiting
Kindai University Hospital
Osakasayama-shi,
JapanActive - Recruiting
Shizuoka Cancer Center
Sunto-gun,
JapanActive - Recruiting
Kanagawa Cancer Center
Yokohama-shi,
JapanActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu,
Korea, Republic ofActive - Recruiting
National Cancer Center
Goyang-si,
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam,
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofActive - Recruiting
Hospital Clinic de Barcelona
Barcelona,
SpainActive - Recruiting
Hospital HM Nou Delfos
Barcelona,
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron - VHIR
Barcelona,
SpainActive - Recruiting
Hospital del Mar
Barcelona,
SpainActive - Recruiting
Hospital Universitario Reina Sofia
Cordoba,
SpainActive - Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat,
SpainActive - Recruiting
Centro Integral Oncologico Clara Campal
Madrid,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid,
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid,
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid,
SpainActive - Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla,
SpainActive - Recruiting
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California 92024
United StatesActive - Recruiting
California Cancer Associates for Research & Excellence, Inc.
Fresno, California 93720
United StatesActive - Recruiting
Piedmont Cancer Institute
Atlanta, Georgia 30318
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesActive - Recruiting
Mary Crowley Cancer Research
Dallas, Texas 75230
United StatesActive - Recruiting
MD Anderson Cancer Center - Oncology
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
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