Metastatic colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy. ;Secondary Objective: To evaluate the overall response rate (ORR), duration of response (DR), disease control rate (DCR), overall survival (OS), safety and tolerability, quality of life (QoL) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy. Exploratory: Evaluate the biomarkers potentially predictive of response and resistance to S 95005 given in combination using blood samples and archived tumour biopsy (if available). ;Primary end point(s): Progression free survival (PFS) ;Timepoint(s) of evaluation of this end point: Tumour measurements within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall Response Rate (ORR). - Duration of Response (DR) - Disease control rate (DCR) - Overall Survival - Safety and tolerability assessed by: ? Incidence of Adverse Events (AE). ? Laboratory tests: haematology, blood biochemistry, coagulation, urinalysis. ? Physical examination and performance status (ECOG). ? Vital signs: blood pressure (BP), heart rate (HR), body temperature, respiration rate, body weight. ? 12-leads ECG parameters. - Quality of Life assessed by a quality of life questionnaire. - Exploratory endpoints:Biomarkers using blood samples and archived tumour biopsy (if available). ;Timepoint(s) of evaluation of this end point: - ORR, DR, DCR: tumour measurements within 28 days prior to Day 1 of Cycle 1 and every 8 weeks thereafter. - Overall Survival: survival status obtained at scheduled 8-week intervals until patient death or end of the study. - Adverse Events: all over the study. - Laboratory tests, physical exam, ECOG, vital signs: within 5 days prior randomisation, at pre-dose of C1D1, C1D15 (except for coagulation, physical exam, ECOG), Day 1 of subsequent cycles, Day 15 of subsequent cycles (only for vital signs and haematology in the experimental arm), withdrawal visit. - Quality of life assessments: every 12 weeks. - Biomarkers measurements: blood samples collected at C1D1 and withdrawal visit. | — |
Countries
Australia, Belgium, Brazil, Denmark, France, Germany, Italy, Netherlands, Poland, Russian Federation, Spain, United Kingdom
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed