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

Metastatic Colorectal Cancer Clinical Trial

— 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743221
• Other study ID #: CL2-95005-002
• Secondary ID: 2015-004544-18
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2016
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2021
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 1, 2020
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Trifluridine/tipiracil + bevacizumab
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
• Capecitabine + bevacizumab
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Locations

Country	Name	City	State
Australia	Chris O'Brien Lifehouse Oncology	Camperdown
Australia	Austin Hospital Olivia Newton-John Cancer & Wellness Centre	Heidelberg
Australia	Western Health, Sunshine Hospital	Saint Albans
Australia	The Queen Elizabeth Hospital Haematology and Oncology Unit	Woodville
Belgium	Grand Hôpital de Charleroi Oncologie-Hématologie	Charleroi
Belgium	UZ Leuven Campus Gasthuisberg Digestieve Oncologie	Leuven
Belgium	CHC Saint-Joseph Oncologie-Hématoimmunopathologie	Liège
Brazil	Hospital do Câncer de Barretos - Fundação Pio XII	Barretos
Brazil	Centro de Pesquisa Hospital de Caridade de Ijuí	Ijui
Brazil	Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica	Rio de Janeiro
Brazil	Hospital de Base, Centro Intergrado de Pesquisa	Sao Jose do Rio Preto
Brazil	Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa	Sao Paulo
Denmark	Rigshospitalet - Dpt of Oncology	Copenhagen
Denmark	Odense Universitetshospital - Department of Oncology	Odense
France	CHU Jean Minjoz, Service d'oncologie médicale	Besançon
France	Hôpital Saint Antoine, oncology department	Paris
France	Centre René Gauducheau, Oncologie Médicale	Saint-Herblain
Germany	Onkologische Schwerpunktpraxis Kurfürstendamm	Berlin
Germany	Schwerpunktpraxis für Hämatologie und Onkologie	Magdeburg
Germany	Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie	Munich
Italy	Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology	Brescia
Italy	A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1	Genova
Italy	A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck	Milan
Italy	Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia	Naples
Italy	.O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2	Pisa
Netherlands	AMC Academisch Medisch Centrum Medische Oncologie	Amsterdam
Netherlands	Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75	Breda
Netherlands	Catharina Ziekenhuis, Interne Geneeskunde/Oncologie	Eindhoven
Netherlands	Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1	Groningen
Netherlands	Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212	Hilversum
Netherlands	Zuyderland Medisch Centrum Interne Geneeskunde	Sittard
Netherlands	Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie	Utrecht
Netherlands	VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210	Venlo
Netherlands	Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2	Zwolle
Poland	Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii	Gdynia
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii	Krakow
Poland	Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii	Warszawa
Poland	NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii	Warszawa
Russian Federation	Moscow City Oncology Hospital # 62, Chemotherapy	Moscow
Russian Federation	Russian Cancer Research Center n.a. NN Blokhin	Moscow
Russian Federation	Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines	Moscow
Russian Federation	Scientific Centre for Specialized Medical Care (oncological)	St Petersburg
Spain	Hospital Valle de Hebrón, Servicio de Oncología	Barcelona
Spain	Hospital Universitario Reina Sofia, Deparatmento Oncología Médica	Cordoba
Spain	Instituto Catalan De Oncología, Hospitalet de Llobregat	Hospitalet de Llobregat
Spain	H. Universitario La Paz Oncología Médica	Madrid
Spain	Hospital Ramón y Cajal, Oncología Médica	Madrid
Spain	Hospital Universitario Gregorio Maranon	Madrid
Spain	Hospital General Universitario, Oncología Médica	Malaga
Spain	Complejo Hospitalario de Navarra, Oncología Médica	Pamplona
United Kingdom	The Beatson West of Scotland Cancer Centre GI cancers	Glasgow
United Kingdom	Leicester Royal Infirmary, The HOPE Clinical Trials Unit	Leicester
United Kingdom	Hammersmith Hospital	London
United Kingdom	Imperial healthcare NHS Trust Charing Cross Hospital	London
United Kingdom	Christie Hospital NHS Foundation Trust, GI & Endocrine	Manchester
United Kingdom	Mount Vernon Hospital Department of Oncology	Northwood
United Kingdom	Southampton General Hospital	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Countries where clinical trial is conducted

Australia,  Belgium,  Brazil,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary	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.	Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary	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.	Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
Secondary	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.	Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary	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.	Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)

External Links

•   First Lay Summary
•   First Results Summary
•   Second Lay Summary
•   Second Results Summary