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

Servier

Status and phase: Active, not recruiting; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Biological: Bevacizumab experimental; Drug: Capecitabine; Drug: Trifluridine/tipiracil hydrochloride (S95005); Biological: Bevacizumab control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03869892

U1111-1206-3198 (Other Identifier)

CL3-95005-006

2017-004059-22 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 856 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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856 participants in 2 patient groups

S95005 + Bevacizumab

Experimental group

Treatment:

Drug: Trifluridine/tipiracil hydrochloride (S95005)

Biological: Bevacizumab experimental

Capecitabine + Bevacizumab

Active Comparator group

Treatment:

Biological: Bevacizumab control

Drug: Capecitabine