An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study) - Phase2 with S95005,bevacizumab,capecitabine in metastatic colorectal cancer

Institut de Recherches Internationales Servier0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- Written informed consent obtained.;- Male or Female participant aged *18 years old.;- Has ECOG 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 anticancer therapy for 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.;- In the judgment of the Investigator, 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.;- Women of childbearing potential must have been tested negative in a serum pregnancy test. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control.;- Is willing and able to comply with scheduled visits and study procedures.

•- Foreseeable poor compliance to the study procedures.;- Is a pregnant or lactating female.;- Is inappropriate for entry into this study in the judgment of the Investigator.;- Has certain serious illness or serious medical condition(s) 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 study drug administration.;- Has previously received S 95005 or history of allergic reactions attributed to compounds of similar or biologic composition to S 95005.;- Has contra indications to bevacizumab or capecitabine.;- Has rare hereditary problems of galectose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

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