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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03869892
Ethics application status
Date submitted
23/02/2018
Date registered
8/03/2019
Date last updated
8/03/2019

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
Other interventions - Bevacizumab experimental
Other interventions - 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.

Other interventions: 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.

Other interventions: 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
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) - Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Overall Survival (OS) - Time elapsed between the date of randomization and the date of death due to any cause.
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Overall response rate (ORR) - 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.
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Disease control rate (DCR) - 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.
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Duration of response (DoR) - 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.
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Time to treatment failure (TTF) - The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
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
Gender
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Frankston Private Peninsula and Southeast Oncology Group - Frankston
Recruitment hospital [2] 0 0
Adventist HealthCare Integrated Cancer Centre - Wahroonga
Recruitment hospital [3] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
St. Poelten
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Brazil
State/province [7] 0 0
Porto Alegre
Country [8] 0 0
Denmark
State/province [8] 0 0
Odense C
Country [9] 0 0
Estonia
State/province [9] 0 0
Tallinn
Country [10] 0 0
Estonia
State/province [10] 0 0
Tartu
Country [11] 0 0
France
State/province [11] 0 0
Avignon
Country [12] 0 0
France
State/province [12] 0 0
Besancon
Country [13] 0 0
France
State/province [13] 0 0
Brest
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Montbeliard
Country [16] 0 0
France
State/province [16] 0 0
Nice
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Poitiers
Country [19] 0 0
Ireland
State/province [19] 0 0
Cork
Country [20] 0 0
Ireland
State/province [20] 0 0
Dublin
Country [21] 0 0
Italy
State/province [21] 0 0
Cagliari
Country [22] 0 0
Italy
State/province [22] 0 0
Cremona
Country [23] 0 0
Italy
State/province [23] 0 0
Napoli
Country [24] 0 0
Italy
State/province [24] 0 0
Padova
Country [25] 0 0
Italy
State/province [25] 0 0
Pisa
Country [26] 0 0
Italy
State/province [26] 0 0
Potenza
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Italy
State/province [28] 0 0
Rozzano (mi)
Country [29] 0 0
Italy
State/province [29] 0 0
San Giovanni Rotondo
Country [30] 0 0
Italy
State/province [30] 0 0
Vicenza
Country [31] 0 0
Lithuania
State/province [31] 0 0
Kaunas
Country [32] 0 0
Lithuania
State/province [32] 0 0
Klaipeda
Country [33] 0 0
Lithuania
State/province [33] 0 0
Vilnius
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Arkhangel'sk
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Barnaul
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Krasnodar
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Kursk
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow Region
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Moscow
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Omsk
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Penza
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Pyatigorsk
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Rostov-on-Don
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Saint Petersburg
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Samara
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Tomsk
Country [47] 0 0
Spain
State/province [47] 0 0
Alicante
Country [48] 0 0
Spain
State/province [48] 0 0
Badalona
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Córdoba
Country [51] 0 0
Spain
State/province [51] 0 0
Granada
Country [52] 0 0
Spain
State/province [52] 0 0
Hospitalet de Llobregat
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Santander
Country [55] 0 0
Spain
State/province [55] 0 0
Valencia
Country [56] 0 0
Spain
State/province [56] 0 0
Zaragoza
Country [57] 0 0
Sweden
State/province [57] 0 0
Falun
Country [58] 0 0
Sweden
State/province [58] 0 0
Jönköping
Country [59] 0 0
Sweden
State/province [59] 0 0
Solna
Country [60] 0 0
Sweden
State/province [60] 0 0
Sundsvall
Country [61] 0 0
Sweden
State/province [61] 0 0
Umeå
Country [62] 0 0
Sweden
State/province [62] 0 0
Uppsala
Country [63] 0 0
Sweden
State/province [63] 0 0
Örebro
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Aberdeen
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Belfast
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Bristol
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Leeds
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Leicester
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Maidstone
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Manchester
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Rhyl
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Sutton
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Wirral
Country [75] 0 0
United Kingdom
State/province [75] 0 0
York

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
The main purpose of this study is to demonstrate the superiority of S 95005 in combination
with bevacizumab over capecitabine in combination with bevacizumab.
Trial website
https://clinicaltrials.gov/show/NCT03869892
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 France75012)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Institut de Recherches Internationales Servier Clinical Studies Department
Address 0 0
Country 0 0
Phone 0 0
+33 1 55 72 43 66
Fax 0 0
Email 0 0
clinicaltrials@servier.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03869892