Phase III study in first-line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy. (SOLSTICE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut De Recherches Internationales Servier IRIS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Apr 2019 → ongoing

Decision date (initial)

2024-10-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Laboratorios Servier, S. L · ADIR France

External identifiers

EU CT number

2024-516180-85-00

EudraCT number

2017-004059-22

WHO UTN

U1111-1206-3198

ClinicalTrials.gov

NCT03869892

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Pharmacogenomic, Safety

To demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab in terms of progression-free survival (PFS) based on Investigator assessment in first-line treatment of patients with unrespectable metastatic colorectal cancer who are not candidate for intensive therapy.

Secondary objectives 1

1. To confirm clinical benefit for treatment through an evaluation of Overall survival (OS), Overall response rate (ORR), Disease control rate (DCR), Duration of response (DoR), Time to treatment failure (TTF) and to compare the safety and the impact on quality of life of S 95005 in combination with bevacizumab to capecitabine in combination with bevacizumab in first-line treatment of patients with unresectable metastatic colorectal cancer who are not candidate for intensive therapy.

Conditions and MedDRA coding

Metastatic colorectal cancer

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Servier’s Data Sharing Policy is available at https://clinicaltrials.servier.com/data-request-portal/. Researchers can ask for a study protocol, patient-level and/or study-level clinical study data including clinical study reports. They can ask for all interventional clinical studies in patients: - Submitted for new medicines and new indications approved after 1 January 2014 in EEA or US. - Where Servier or an affiliate are the Marketing Authorisation Holders (MAH). The date of the first Marketing Authorisation (MA) of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope. In addition, Servier’s data sharing policy includes all interventional clinical studies in patients: sponsored by Servier, with a first patient enrolled as of 1 January 2004 onwards, for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any MA approval.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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 9

1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
2. Participation in another interventional study within 4 weeks prior to the randomisation .
3. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
4. Symptomatic central nervous system metastases.
5. Major surgery within 4 weeks prior to the randomisation.
6. 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.
7. Any contraindication present in the SmPC of trifluridine/tipiracil
8. Exclusion criteria related to bevacizumab administration: Any contraindication present in the SmPC of bevacizumab
9. Exclusion criteria related to capecitabine administration: Any contraindication present in the SmPC of capecitabine

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS) based on investigator judgement

Secondary endpoints 7

1. Overall survival (OS)
2. Overall response rate (ORR)
3. Disease control rate (DCR)
4. Duration of response (DoR)
5. Time to treatment failure (TTF)
6. Safety and tolerability assessed by incidence of adverse events (AE), laboratory tests, physical examination and performance status (ECOG), vital signs, 12-leads ECG parameters
7. Quality of life (QoL)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut De Recherches Internationales Servier IRIS

Sponsor organisation

Institut De Recherches Internationales Servier IRIS

Address

22 Route 128

City

Gif Sur Yvette

Postcode

91190

Country

France

Scientific contact point

Organisation

Institut De Recherches Internationales Servier IRIS

Contact name

Clinical Studies Department

Public contact point

Organisation

Institut De Recherches Internationales Servier IRIS

Contact name

Clinical Studies Department

Third parties 7

Locations

4 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications