Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Phase 3

Active, not recruiting

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Trifluridine/tipiracil hydrochloride (S95005); Drug: Capecitabine; Biological: Bevacizumab experimental; Biological: Bevacizumab control

• Registration Number: NCT03869892
• Lead Sponsor: Institut de Recherches Internationales Servier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-03-21
• Primary Completion: 2021-06-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 856

Inclusion Criteria

1. Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
2. 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).
3. Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
4. Patient is not a candidate for curative resection of metastatic lesions.
5. No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
6. ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
7. Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'

Exclusion Criteria

8. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.

9. Participation in another interventional study within 4 weeks prior to the randomisation .

10. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.

11. Symptomatic central nervous system metastases.

12. Major surgery within 4 weeks prior to the randomisation.

    Exclusion criteria related to S 95005 administration:

13. History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.

14. Any contraindication present in the SmPC of trifluridine/tipiracil

    Exclusion criteria related to bevacizumab administration:

15. Any contraindication present in the SmPC of bevacizumab

    Exclusion criteria related to capecitabine administration:

16. Any contraindication present in the SmPC of capecitabine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S95005 + Bevacizumab	Trifluridine/tipiracil hydrochloride (S95005)	-
S95005 + Bevacizumab	Bevacizumab experimental	-
Capecitabine + Bevacizumab	Capecitabine	-
Capecitabine + Bevacizumab	Bevacizumab control	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Up to 24 months	Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 24 months	Time elapsed between the date of randomization and the date of death due to any cause.
Overall response rate (ORR)	Up to 24 months	The proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and using investigator's tumour assessment.
Disease control rate (DCR)	Up to 24 months	The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1 criteria and using investigator's tumour assessment.
Duration of response (DoR)	Up to 24 months	The time from the first documentation of response (CR or PR) to the first documentation of objective tumour progression or death due to any cause, whichever occurs first.
Time to treatment failure (TTF)	Up to 24 months	The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

Trial Locations

Locations (189)

Centro de Oncología e Investigación de Buenos Aires COIBA; 🇦🇷 Berazategui, Argentina

Fundación Favaloro Oncology Unit; 🇦🇷 Buenos Aires, Argentina

Instituto Alexander Fleming; 🇦🇷 Ciudad Autonoma de Buenos aires, Argentina

Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales; 🇦🇷 Ciudad Autonoma de Buenos aires, Argentina

Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer; 🇦🇷 La Rioja, Argentina

Fundación COIR Centro Oncológico de Interación Regional; 🇦🇷 Mendoza, Argentina

Instituto de Oncología de Rosario; 🇦🇷 Santa Fe, Argentina

ISIS Centro especializado; 🇦🇷 Santa Fe, Argentina

Centro Médico San Roque; 🇦🇷 Tucumán, Argentina

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