Back to resultsA Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1)
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Trifluridine/tipiracil + bevacizumab
Capecitabine + bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring metastatic, colorectal, cancer, untreated, first-line, S95005 (Trifluridine/tipiracil), bevacizumab, capecitabine
Eligibility Criteria
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.
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.
Sites / Locations
- Chris O'Brien Lifehouse Oncology
- Austin Hospital Olivia Newton-John Cancer & Wellness Centre
- Western Health, Sunshine Hospital
- The Queen Elizabeth Hospital Haematology and Oncology Unit
- Grand Hôpital de Charleroi Oncologie-Hématologie
- UZ Leuven Campus Gasthuisberg Digestieve Oncologie
- CHC Saint-Joseph Oncologie-Hématoimmunopathologie
- Hospital do Câncer de Barretos - Fundação Pio XII
- Centro de Pesquisa Hospital de Caridade de Ijuí
- Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica
- Hospital de Base, Centro Intergrado de Pesquisa
- Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa
- Rigshospitalet - Dpt of Oncology
- Odense Universitetshospital - Department of Oncology
- CHU Jean Minjoz, Service d'oncologie médicale
- Hôpital Saint Antoine, oncology department
- Centre René Gauducheau, Oncologie Médicale
- Onkologische Schwerpunktpraxis Kurfürstendamm
- Schwerpunktpraxis für Hämatologie und Onkologie
- Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie
- Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology
- A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1
- A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck
- Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia
- .O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2
- AMC Academisch Medisch Centrum Medische Oncologie
- Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75
- Catharina Ziekenhuis, Interne Geneeskunde/Oncologie
- Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1
- Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212
- Zuyderland Medisch Centrum Interne Geneeskunde
- Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie
- VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210
- Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2
- Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
- SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
- Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii
- NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii
- Russian Cancer Research Center n.a. NN Blokhin
- Moscow City Oncology Hospital # 62, Chemotherapy
- Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines
- Scientific Centre for Specialized Medical Care (oncological)
- Hospital Valle de Hebrón, Servicio de Oncología
- Hospital Universitario Reina Sofia, Deparatmento Oncología Médica
- Instituto Catalan De Oncología, Hospitalet de Llobregat
- Hospital Universitario Gregorio Maranon
- Hospital Ramón y Cajal, Oncología Médica
- H. Universitario La Paz Oncología Médica
- Hospital General Universitario, Oncología Médica
- Complejo Hospitalario de Navarra, Oncología Médica
- The Beatson West of Scotland Cancer Centre GI cancers
- Leicester Royal Infirmary, The HOPE Clinical Trials Unit
- Hammersmith Hospital
- Imperial healthcare NHS Trust Charing Cross Hospital
- Christie Hospital NHS Foundation Trust, GI & Endocrine
- Mount Vernon Hospital Department of Oncology
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trifluridine/tipiracil + bevacizumab
Capecitabine + bevacizumab
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.
Secondary Outcome Measures
Overall Response Rate (ORR)
As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.
Duration of Response (DR)
The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Disease Control Rate (DCR)
DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.
Overall Survival (OS)
The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.
Full Information
NCT ID
NCT02743221
First Posted
February 24, 2016
Last Updated
October 3, 2021
Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company
1. Study Identification
Unique Protocol Identification Number
NCT02743221
Brief 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
Acronym
TASCO1
Official 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).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 29, 2016 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier
Collaborators
ADIR, a Servier Group company
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
metastatic, colorectal, cancer, untreated, first-line, S95005 (Trifluridine/tipiracil), bevacizumab, capecitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trifluridine/tipiracil + bevacizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Capecitabine + bevacizumab
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Trifluridine/tipiracil + bevacizumab
Intervention Description
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
Intervention Type
Drug
Intervention Name(s)
Capecitabine + bevacizumab
Intervention Description
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.
Time Frame
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.
Time Frame
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Title
Duration of Response (DR)
Description
The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Time Frame
Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Title
Disease Control Rate (DCR)
Description
DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.
Time Frame
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Title
Overall Survival (OS)
Description
The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.
Time Frame
Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Van Custem, Prof
Organizational Affiliation
Leuven Cancer Institute, University Hospitals Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chris O'Brien Lifehouse Oncology
City
Camperdown
ZIP/Postal Code
NSW 2050
Country
Australia
Facility Name
Austin Hospital Olivia Newton-John Cancer & Wellness Centre
City
Heidelberg
ZIP/Postal Code
VIC 3084
Country
Australia
Facility Name
Western Health, Sunshine Hospital
City
Saint Albans
ZIP/Postal Code
VIC 3021
Country
Australia
Facility Name
The Queen Elizabeth Hospital Haematology and Oncology Unit
City
Woodville
ZIP/Postal Code
SA 5011
Country
Australia
Facility Name
Grand Hôpital de Charleroi Oncologie-Hématologie
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Leuven Campus Gasthuisberg Digestieve Oncologie
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHC Saint-Joseph Oncologie-Hématoimmunopathologie
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Hospital do Câncer de Barretos - Fundação Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Centro de Pesquisa Hospital de Caridade de Ijuí
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Hospital de Base, Centro Intergrado de Pesquisa
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Rigshospitalet - Dpt of Oncology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital - Department of Oncology
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU Jean Minjoz, Service d'oncologie médicale
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Saint Antoine, oncology department
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre René Gauducheau, Oncologie Médicale
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Schwerpunktpraxis für Hämatologie und Onkologie
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie
City
Munich
ZIP/Postal Code
81737
Country
Germany
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
.O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
AMC Academisch Medisch Centrum Medische Oncologie
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Catharina Ziekenhuis, Interne Geneeskunde/Oncologie
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum Interne Geneeskunde
City
Sittard
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie
City
Utrecht
ZIP/Postal Code
3543 CX
Country
Netherlands
Facility Name
VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii
City
Warszawa
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Russian Cancer Research Center n.a. NN Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital # 62, Chemotherapy
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines
City
Moscow
Country
Russian Federation
Facility Name
Scientific Centre for Specialized Medical Care (oncological)
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Hospital Valle de Hebrón, Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Reina Sofia, Deparatmento Oncología Médica
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Instituto Catalan De Oncología, Hospitalet de Llobregat
City
Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramón y Cajal, Oncología Médica
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
H. Universitario La Paz Oncología Médica
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital General Universitario, Oncología Médica
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Hospitalario de Navarra, Oncología Médica
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
The Beatson West of Scotland Cancer Centre GI cancers
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Leicester Royal Infirmary, The HOPE Clinical Trials Unit
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Imperial healthcare NHS Trust Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust, GI & Endocrine
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Hospital Department of Oncology
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing Access Criteria
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.
IPD Sharing URL
http://clinicaltrials.servier.com
Citations:
PubMed Identifier
35440667
Citation
Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Fougeray R, Egorov A, Amellal N, Moiseyenko V. First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. Br J Cancer. 2022 Jun;126(11):1548-1554. doi: 10.1038/s41416-022-01737-2. Epub 2022 Apr 19.
Results Reference
derived
PubMed Identifier
32497736
Citation
Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Kanehisa A, Egorov A, Aubel P, Amellal N, Moiseenko V. Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study. Ann Oncol. 2020 Sep;31(9):1160-1168. doi: 10.1016/j.annonc.2020.05.024. Epub 2020 Jun 1.
Results Reference
derived
Links:
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-95005-002_lay-summary.pdf
Description
First Lay Summary
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-95005-002-anonymised-synopsis.pdf
Description
First Results Summary
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-095005-002-laysummary-2021.09.24.pdf
Description
Second Lay Summary
URL
https://clinicaltrials.servier.com/wp-content/uploads/CL2-095005-002-anonymisedsynopsis-2021.03.15.pdf
Description
Second Results Summary
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://clinicaltrials.servier.com/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
study-level clinical trial data
Available IPD/Information URL
https://clinicaltrials.servier.com/
Learn more about this trial
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
We'll reach out to this number within 24 hrs