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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03306394




Registration number
NCT03306394
Ethics application status
Date submitted
2/08/2017
Date registered
11/10/2017

Titles & IDs
Public title
A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).
Scientific title
An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)
Secondary ID [1] 0 0
2016-002311-18
Secondary ID [2] 0 0
CL3-95005-004
Universal Trial Number (UTN)
Trial acronym
PRECONNECT
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
Experimental: S95005 - Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events [safety and tolerability]
Timepoint [1] 0 0
Through 28 days following last administration of study medication
Primary outcome [2] 0 0
Abnormalities in laboratory assessment
Timepoint [2] 0 0
Through study completion, an average of 12 weeks
Primary outcome [3] 0 0
Abnormalities in performance status (ECOG)
Timepoint [3] 0 0
Through study completion, an average of 12 weeks
Primary outcome [4] 0 0
Abnormalities in vital signs
Timepoint [4] 0 0
Through study completion, an average of 12 weeks
Secondary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
Through study completion, an average of 12 weeks
Secondary outcome [2] 0 0
Quality of life using the questionnaire EQ-5D
Timepoint [2] 0 0
Through study completion, an average of 12 weeks
Secondary outcome [3] 0 0
Quality of life using the questionnaire EORTC QLQ-C30
Timepoint [3] 0 0
Through study completion, an average of 12 weeks

Eligibility
Key inclusion criteria
* Male or Female participant aged =18 years old.
* Has definitive histologically confirmed adenocarcinoma of the colon or rectum.
* Has metastatic lesion(s).
* Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period.
* Is able to take medications orally (i.e., no feeding tube).
* Has adequate organ function.
* Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. 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
* Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
* Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil.
* Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil.
* Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
* Has certain serious illness or medical condition(s) described in the protocol.
* Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration.
* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 3
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
18/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2020
Sample size
Target
Accrual to date
Final
907
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse Oncology - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital The Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [3] 0 0
St Vincent's Hospital (Melbourne) Cancer Centre - Fitzroy
Recruitment hospital [4] 0 0
The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19 - Garran
Recruitment hospital [5] 0 0
Royal Brisbane & Women's Hospital Clinical Research Unit - Herston
Recruitment hospital [6] 0 0
Cabrini Hospital Cabrini Haematology and Oncology Centre - Malvern
Recruitment hospital [7] 0 0
Perth Oncology - Mount Hospital - Perth
Recruitment hospital [8] 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
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
2605 - Garran
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
SA 5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Brazil
State/province [5] 0 0
Porto Alegre
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio De Janeiro
Country [7] 0 0
Brazil
State/province [7] 0 0
Salvador
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Plovdiv
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Varna
Country [12] 0 0
Croatia
State/province [12] 0 0
Rijeka
Country [13] 0 0
Croatia
State/province [13] 0 0
Zagreb
Country [14] 0 0
France
State/province [14] 0 0
Arras
Country [15] 0 0
France
State/province [15] 0 0
Avignon
Country [16] 0 0
France
State/province [16] 0 0
Caen
Country [17] 0 0
France
State/province [17] 0 0
Chambray Les Tours
Country [18] 0 0
France
State/province [18] 0 0
Dijon
Country [19] 0 0
France
State/province [19] 0 0
Grenoble Cedex 9
Country [20] 0 0
France
State/province [20] 0 0
La Roche Sur Yon
Country [21] 0 0
France
State/province [21] 0 0
Levallois Perret
Country [22] 0 0
France
State/province [22] 0 0
Lyon
Country [23] 0 0
France
State/province [23] 0 0
Marseille
Country [24] 0 0
France
State/province [24] 0 0
Montbeliard
Country [25] 0 0
France
State/province [25] 0 0
Montpellier
Country [26] 0 0
France
State/province [26] 0 0
Nice
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pessac
Country [29] 0 0
France
State/province [29] 0 0
Poitiers
Country [30] 0 0
France
State/province [30] 0 0
Reims
Country [31] 0 0
France
State/province [31] 0 0
Rennes
Country [32] 0 0
France
State/province [32] 0 0
Saint Etienne
Country [33] 0 0
France
State/province [33] 0 0
TOULOUSE cedex 9
Country [34] 0 0
Ireland
State/province [34] 0 0
Cork
Country [35] 0 0
Ireland
State/province [35] 0 0
Dublin
Country [36] 0 0
Italy
State/province [36] 0 0
Bari
Country [37] 0 0
Italy
State/province [37] 0 0
Brescia
Country [38] 0 0
Italy
State/province [38] 0 0
Catania
Country [39] 0 0
Italy
State/province [39] 0 0
Firenze
Country [40] 0 0
Italy
State/province [40] 0 0
Meldola
Country [41] 0 0
Italy
State/province [41] 0 0
Milano
Country [42] 0 0
Italy
State/province [42] 0 0
Napoli
Country [43] 0 0
Italy
State/province [43] 0 0
Padova
Country [44] 0 0
Italy
State/province [44] 0 0
Palermo
Country [45] 0 0
Italy
State/province [45] 0 0
Pescara
Country [46] 0 0
Italy
State/province [46] 0 0
Pisa
Country [47] 0 0
Italy
State/province [47] 0 0
Reggio Emilia
Country [48] 0 0
Italy
State/province [48] 0 0
Rimini
Country [49] 0 0
Italy
State/province [49] 0 0
Roma
Country [50] 0 0
Italy
State/province [50] 0 0
Rozzano (mi)
Country [51] 0 0
Italy
State/province [51] 0 0
San Giovanni Rotondo
Country [52] 0 0
Italy
State/province [52] 0 0
Torino
Country [53] 0 0
Panama
State/province [53] 0 0
Panamá
Country [54] 0 0
Poland
State/province [54] 0 0
Bialystok
Country [55] 0 0
Poland
State/province [55] 0 0
Gdansk
Country [56] 0 0
Poland
State/province [56] 0 0
Opole
Country [57] 0 0
Poland
State/province [57] 0 0
Poznan
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Portugal
State/province [59] 0 0
Almada
Country [60] 0 0
Portugal
State/province [60] 0 0
Coimbra
Country [61] 0 0
Portugal
State/province [61] 0 0
Lisboa
Country [62] 0 0
Portugal
State/province [62] 0 0
Porto
Country [63] 0 0
Romania
State/province [63] 0 0
Bucuresti
Country [64] 0 0
Romania
State/province [64] 0 0
Cluj-napoca
Country [65] 0 0
Romania
State/province [65] 0 0
Iasi
Country [66] 0 0
Slovakia
State/province [66] 0 0
Bratislava
Country [67] 0 0
Slovakia
State/province [67] 0 0
Kosice
Country [68] 0 0
Slovenia
State/province [68] 0 0
Ljubljana
Country [69] 0 0
Turkey
State/province [69] 0 0
Ankara
Country [70] 0 0
Turkey
State/province [70] 0 0
Bursa
Country [71] 0 0
Turkey
State/province [71] 0 0
Edirne
Country [72] 0 0
Turkey
State/province [72] 0 0
Istanbul
Country [73] 0 0
Turkey
State/province [73] 0 0
Izmir
Country [74] 0 0
Turkey
State/province [74] 0 0
Kayseri
Country [75] 0 0
Ukraine
State/province [75] 0 0
Kharkiv
Country [76] 0 0
Ukraine
State/province [76] 0 0
Kiev
Country [77] 0 0
Ukraine
State/province [77] 0 0
Kyiv
Country [78] 0 0
Ukraine
State/province [78] 0 0
Odesa

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
Address 0 0
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?

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/NCT03306394