A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut de Recherches Internationales Servier
With
ADIR, a Servier Group company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent obtained.
Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
RAS status must have been determined (mutant or wild).
Has at least one measurable metastatic lesion.
No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
Is able to take medication orally (i.e., no feeding tube).
Has adequate organ function.
Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.
You may not be if
Is a pregnant or lactating female.
Has certain serious illness or serious medical condition(s) as described in the protocol.
Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Has contra-indication to bevacizumab or capecitabine.
Clareo Health | A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
