Status:
ACTIVE_NOT_RECRUITING
Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
ADIR, a Servier Group company
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
Eligibility Criteria
Inclusion
- Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
- RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
- Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
- Patient is not a candidate for curative resection of metastatic lesions.
- No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'
Exclusion
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- Participation in another interventional study within 4 weeks prior to the randomisation .
- Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
- Symptomatic central nervous system metastases.
- Major surgery within 4 weeks prior to the randomisation.
- Exclusion criteria related to S 95005 administration:
- History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
- Any contraindication present in the SmPC of trifluridine/tipiracil
- Exclusion criteria related to bevacizumab administration:
- Any contraindication present in the SmPC of bevacizumab
- Exclusion criteria related to capecitabine administration:
- Any contraindication present in the SmPC of capecitabine
Key Trial Info
Start Date :
March 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
856 Patients enrolled
Trial Details
Trial ID
NCT03869892
Start Date
March 21 2019
End Date
December 31 2026
Last Update
December 22 2025
Active Locations (190)
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1
Centro de Oncología e Investigación de Buenos Aires COIBA
Berazategui, Argentina, B1884BBF
2
Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit
Buenos Aires, Argentina, 1264
3
Fundación Favaloro Oncology Unit
Buenos Aires, Argentina, C1093AAS
4
Instituto Alexander Fleming
Buenos Aires, Argentina, C1426ANZ