Phase
Condition
Colorectal Cancer
Colon Cancer; Rectal Cancer
Colon 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,
CanadaSite Not Available
The Ottawa Hospital Cancer Centre
Ottawa 6094817,
CanadaActive - Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto,
CanadaSite Not Available
University Health Network - Princess Margaret Cancer Centre
Toronto 6167865,
CanadaActive - Recruiting
National Cancer Center Hospital - Dept of Gastroenterology
Chuo-ku,
JapanSite Not Available
National Cancer Center Hospital - Dept of Gastroenterology
Chūōku 10262791,
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,
JapanSite Not Available
Cancer Institute Hospital of JFCR
Kōtoku 2128852,
JapanActive - Recruiting
Aichi Cancer Center Hospital
Nagoya 1856057,
JapanActive - Recruiting
Aichi Cancer Center Hospital
Nagoya-shi,
JapanSite Not Available
Kindai University Hospital
Osakasayama-shi,
JapanActive - Recruiting
Shizuoka Cancer Center
Sunto-gun,
JapanActive - Recruiting
Kanagawa Cancer Center
Yokohama 1848354,
JapanActive - Recruiting
Kanagawa Cancer Center
Yokohama-shi,
JapanSite Not Available
Kyungpook National University Chilgok Hospital
Daegu,
Korea, Republic ofSite Not Available
National Cancer Center
Goyang-si,
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam,
Korea, Republic ofSite Not Available
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 ofSite Not Available
Kyungpook National University Chilgok Hospital
Daegu 1835329,
South KoreaActive - Recruiting
National Cancer Center
Goyang-si 1842485,
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam 6876792,
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848,
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848,
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848,
South KoreaActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul 1835848,
South KoreaActive - 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,
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona 3128760,
SpainActive - Recruiting
Hospital HM Nou Delfos
Barcelona 3128760,
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron - VHIR
Barcelona 3128760,
SpainActive - Recruiting
Hospital del Mar
Barcelona 3128760,
SpainActive - Recruiting
Hospital Universitario Reina Sofia
Cordoba,
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba 2519240,
SpainActive - Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat,
SpainSite Not Available
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat 3120619,
SpainActive - Recruiting
Centro Integral Oncologico Clara Campal
Madrid,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid,
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz
Madrid,
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid,
SpainActive - Recruiting
Centro Integral Oncologico Clara Campal
Madrid 3117735,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid 3117735,
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid 3117735,
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid 3117735,
SpainActive - Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela,
SpainSite Not Available
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela 3109642,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla,
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Seville 2510911,
SpainActive - Recruiting
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California 92024
United StatesSite Not Available
California Cancer Associates for Research & Excellence, Inc.
Fresno, California 93720
United StatesSite Not Available
California Cancer Associates for Research & Excellence, Inc.
Encinitas 5346646, California 5332921 92024
United StatesCompleted
California Cancer Associates for Research & Excellence, Inc.
Fresno 5350937, California 5332921 93720
United StatesCompleted
Piedmont Cancer Institute
Atlanta, Georgia 30318
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
United StatesActive - Recruiting
Mary Crowley Cancer Research
Dallas, Texas 75230
United StatesSite Not Available
MD Anderson Cancer Center - Oncology
Houston, Texas 77030
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
Mary Crowley Cancer Research
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
MD Anderson Cancer Center - Oncology
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
NEXT Oncology
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting

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