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 (TASCO1)
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ClinicalTrials.gov Identifier: NCT02743221 |
Recruitment Status :
Completed
First Posted : April 19, 2016
Results First Posted : April 16, 2019
Last Update Posted : October 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Colorectal Cancer | Drug: Trifluridine/tipiracil + bevacizumab Drug: Capecitabine + bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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). |
Actual Study Start Date : | April 29, 2016 |
Actual Primary Completion Date : | January 15, 2018 |
Actual Study Completion Date : | September 1, 2020 |
Arm | Intervention/treatment |
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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. |
Drug: Trifluridine/tipiracil + bevacizumab
Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion. |
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
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Drug: Capecitabine + bevacizumab
Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion. |
- Progression Free Survival (PFS) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) ]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.
- Overall Response Rate (ORR) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) ]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) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months) ]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) [ Time Frame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) ]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) [ Time Frame: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months) ]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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743221
Principal Investigator: | Eric Van Custem, Prof | Leuven Cancer Institute, University Hospitals Leuven |
Documents provided by Servier ( Institut de Recherches Internationales Servier ):
Study Data/Documents: Individual Participant Data Set
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Institut de Recherches Internationales Servier |
ClinicalTrials.gov Identifier: | NCT02743221 |
Other Study ID Numbers: |
CL2-95005-002 2015-004544-18 ( EudraCT Number ) |
First Posted: | April 19, 2016 Key Record Dates |
Results First Posted: | April 16, 2019 |
Last Update Posted: | October 5, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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:
In addition, access can be requested for all interventional clinical studies in patients:
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Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | After Marketing Authorisation in EEA or US if the study is used for the approval. |
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. |
URL: | http://clinicaltrials.servier.com |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
metastatic colorectal cancer untreated |
first-line S95005 (Trifluridine/tipiracil) bevacizumab capecitabine |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Trifluridine Bevacizumab |
Capecitabine Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |