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)
- Conditions
- 10017991metastatic colorectal cancer
- Registration Number
- NL-OMON43475
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression-free survival (PFS) based on Investigator assessment of radiologic<br /><br>images</p><br>
- Secondary Outcome Measures
Name Time Method <p> Overall response rate (ORR)<br /><br> Duration of response (DR)<br /><br> Disease control rate (DCR)<br /><br> Overall survival (OS)<br /><br> Safety and tolerability<br /><br> Quality of Life (QoL)</p><br>