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NCT Number: NCT03869892

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

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Oncología e Investigación de Buenos Aires COIBA, Berazategui, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Trifluridine/tipiracil hydrochloride (S95005)

Drug

Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.

Capecitabine

Drug

Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.

Bevacizumab experimental

Biological

Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.

Bevacizumab control

Biological

Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: Up to 8 years

    Time elapsed between the date of randomization and the date of death due to any cause.

  2. Overall response rate (ORR)

    Time frame: Up to 8 years

    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.

  3. Disease control rate (DCR)

    Time frame: Up to 8 years

    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.

  4. Duration of response (DoR)

    Time frame: Up to 8 years

    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.

  5. Time to treatment failure (TTF)

    Time frame: Up to 8 years

    The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

  6. Incidence of Adverse Events (AEs)

    Time frame: Up to 8 years

  7. Number of clinically significant changes to hematology, biochemistry, coagulation and urinalysis tests

    Time frame: Up to 8 years

  8. Changes in ECOG performance status

    Time frame: Up to 8 years

  9. Number of clinically significant changes to blood pressure, heart rate, body temperature and body weight

    Time frame: Up to 8 years

  10. Number of clinically significant changes to 12-leads ECG parameters

    Time frame: Up to 8 years

  11. Quality of life as assessed by EORTC QLQ-C30

    Time frame: Up to 8 years

    European organization for research and treatment of cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire (QLQ-C30) scores range from 0-100 and assess functional and symptom scores. For functional scores, a higher score represents an increase in functioning. For symptom scores, a higher score represents an increase in symptoms.

  12. Quality of life as assessed by EQ-5D-5L

    Time frame: Up to 8 years

    The 5-level EQ-5D version questionnaire scores range from 5 to 25 with a higher score representing a worse health status.

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study title

An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)

Acronym: SOLSTICE

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Mar 11, 2019
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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