An open-label, randomised, phase 2 study comparing S 95005 plus bevacizumab to capecitabine plus bevacizumab in patients with previously untreated metastatic colorectal cancer who are non-eligible for intensive therapy

aboratorios Servier S.L.0 个研究点目标入组 154 人开始时间: 2016年2月19日最近更新: 2022年4月19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.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•- 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.

发起方

aboratorios Servier S.L.