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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03869892




Registration number
NCT03869892
Ethics application status
Date submitted
23/02/2018
Date registered
11/03/2019

Titles & IDs
Public title
Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
Scientific 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)
Secondary ID [1] 0 0
2017-004059-22
Secondary ID [2] 0 0
CL3-95005-006
Universal Trial Number (UTN)
Trial acronym
SOLSTICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trifluridine/tipiracil hydrochloride (S95005)
Treatment: Drugs - Capecitabine
Treatment: Other - Bevacizumab experimental
Treatment: Other - Bevacizumab control

Experimental: S95005 + Bevacizumab -

Active comparator: Capecitabine + Bevacizumab -


Treatment: Drugs: Trifluridine/tipiracil hydrochloride (S95005)
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.

Treatment: Drugs: Capecitabine
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.

Treatment: Other: Bevacizumab experimental
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.

Treatment: Other: Bevacizumab control
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Overall response rate (ORR)
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Time to treatment failure (TTF)
Timepoint [5] 0 0
Up to 24 months

Eligibility
Key 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'
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
Accrual to date
Final
856
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Blacktown Hospital Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Frankston Private Peninsula and Southeast Oncology Group - Frankston
Recruitment hospital [3] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [4] 0 0
St George Hospital St George Hospital Cancer Care Centre - Kogarah
Recruitment hospital [5] 0 0
Adventist HealthCare Integrated Cancer Centre - Wahroonga
Recruitment hospital [6] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
2290 - Gateshead
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2076 - Wahroonga
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Argentina
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Berazategui
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos aires
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Ciudad Autónoma de Buenos Aires
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Santa Fe
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Graz
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Innsbruck
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Linz
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Salzburg
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St. Poelten
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Wien
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Barretos
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Belo Horizonte
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Brasília
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Ijuí
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Porto Alegre
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Salvador
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Santo André
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São José Do Rio Preto
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São Paulo
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Bulgaria
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Burgas
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Gabrovo
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Plovdiv
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Sofia
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Varna
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Vratsa
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Czechia
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Brno
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Ostrava
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Praha
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Aalborg
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Herning
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Luebeck
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Muenchen
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Gyor
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Szolnok
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Pisa
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Potenza
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Roma
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Rozzano (mi)
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San Giovanni Rotondo
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Riga
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Sibiu
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Rostov-on-Don
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Saint Petersburg
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Samara
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Sochi
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Russian Federation
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Tomsk
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Russian Federation
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Yaroslavl
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Slovakia
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Bratislava
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Slovakia
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Košice
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Falun
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Sweden
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Jönköping
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Sweden
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Solna
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Sweden
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Umeå
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Sweden
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Örebro
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Ukraine
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Cherkasy
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Ukraine
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Dnipro
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
Country [138] 0 0
Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Vinnytsya
Country [141] 0 0
Ukraine
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Zaporozhye
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Aberdeen
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United Kingdom
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Bristol
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
Country [147] 0 0
United Kingdom
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Manchester
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Rhyl
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Other
Name
Institut de Recherches Internationales Servier
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ADIR, a Servier Group company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thierry ANDRE, PhD
Address 0 0
Medical Oncology departement Saint-Antoine hospital (Paris France 75012)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for 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 Marketing authorization (MA) approval.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
After Marketing Authorisation in EEA or US if the study is used for the approval.
Available to whom?
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicaltrials.servier.com/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03869892