A phase 2 study evaluating S 95005 plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated colorectal cancer who are non-eligible for intensive therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

- 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 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.
- 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

Exclusion Criteria

- 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 randomisation.
- Has previously received S 95005 or history of allergic reactions attributed to compounds of similar composition to S 95005 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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