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

Phase 1

• Conditions: Metastatic colorectal cancer; MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004544-18-DE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 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

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 study drug administration.
- Has previously received S 95005 or history of allergic reactions attributed to compounds of similar or biologic composition to S 95005.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified