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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02743221




Registration number
NCT02743221
Ethics application status
Date submitted
24/02/2016
Date registered
19/04/2016

Titles & IDs
Public title
A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
Scientific title
An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).
Secondary ID [1] 0 0
2015-004544-18
Secondary ID [2] 0 0
CL2-95005-002
Universal Trial Number (UTN)
Trial acronym
TASCO1
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 + bevacizumab
Treatment: Drugs - Capecitabine + bevacizumab

Experimental: Trifluridine/tipiracil + bevacizumab - Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride.

Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab.

Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.

Active comparator: Capecitabine + bevacizumab - Capecitabine was administered at 1250 mg/m² orally BID (bis in die)on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks


Treatment: Drugs: Trifluridine/tipiracil + bevacizumab
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.

Treatment: Drugs: Capecitabine + bevacizumab
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary outcome [2] 0 0
Duration of Response (DR)
Timepoint [2] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)

Eligibility
Key inclusion criteria
* Written informed consent obtained.
* Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
* Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
* RAS status must have been determined (mutant or wild).
* Has at least one measurable metastatic lesion.
* No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
* Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
* Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
* Is able to take medication orally (i.e., no feeding tube).
* Has adequate organ function.
* Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
* Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is a pregnant or lactating female.
* Has certain serious illness or serious medical condition(s) as described in the protocol.
* Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
* Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
* Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
* Has contra-indication to bevacizumab or 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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2020
Sample size
Target
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse Oncology - Camperdown
Recruitment hospital [2] 0 0
Austin Hospital Olivia Newton-John Cancer & Wellness Centre - Heidelberg
Recruitment hospital [3] 0 0
Western Health, Sunshine Hospital - Saint Albans
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital Haematology and Oncology Unit - Woodville
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [2] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
VIC 3021 - Saint Albans
Recruitment postcode(s) [4] 0 0
SA 5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Charleroi
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Brazil
State/province [4] 0 0
Barretos
Country [5] 0 0
Brazil
State/province [5] 0 0
Ijui
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio de Janeiro
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Jose do Rio Preto
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Denmark
State/province [9] 0 0
Copenhagen
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense
Country [11] 0 0
France
State/province [11] 0 0
Besançon
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Saint-Herblain
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Magdeburg
Country [16] 0 0
Germany
State/province [16] 0 0
Munich
Country [17] 0 0
Italy
State/province [17] 0 0
Brescia
Country [18] 0 0
Italy
State/province [18] 0 0
Genova
Country [19] 0 0
Italy
State/province [19] 0 0
Milan
Country [20] 0 0
Italy
State/province [20] 0 0
Naples
Country [21] 0 0
Italy
State/province [21] 0 0
Pisa
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Breda
Country [24] 0 0
Netherlands
State/province [24] 0 0
Eindhoven
Country [25] 0 0
Netherlands
State/province [25] 0 0
Groningen
Country [26] 0 0
Netherlands
State/province [26] 0 0
Hilversum
Country [27] 0 0
Netherlands
State/province [27] 0 0
Sittard
Country [28] 0 0
Netherlands
State/province [28] 0 0
Utrecht
Country [29] 0 0
Netherlands
State/province [29] 0 0
Venlo
Country [30] 0 0
Netherlands
State/province [30] 0 0
Zwolle
Country [31] 0 0
Poland
State/province [31] 0 0
Gdynia
Country [32] 0 0
Poland
State/province [32] 0 0
Krakow
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Moscow
Country [35] 0 0
Russian Federation
State/province [35] 0 0
St Petersburg
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Cordoba
Country [38] 0 0
Spain
State/province [38] 0 0
Hospitalet de Llobregat
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Malaga
Country [41] 0 0
Spain
State/province [41] 0 0
Pamplona
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Glasgow
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Leicester
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Northwood
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Southampton

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
Eric Van Custem, Prof
Address 0 0
Leuven Cancer Institute, University Hospitals Leuven
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: http://clinicaltrials.servier.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02743221