ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CL2-95005-002
Previous Study | Return to List | Next Study

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02743221
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Trifluridine/tipiracil hydrochloride (S 95005) Drug: Capecitabine Drug: Bevacizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 2016
Actual Primary Completion Date : January 15, 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: S 95005 + bevacizumab Drug: Trifluridine/tipiracil hydrochloride (S 95005)
film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m2/dose, until a discontinuation criterion is met

Drug: Bevacizumab
concentrate for solution for infusion containing 25mg/ml of bevacizumab administered intravenously at the dose of 5 mg/kg, until a discontinuation criterion is met

Active Comparator: Capecitabine + bevacizumab Drug: Capecitabine
Capecitabine film-coated tablets containing 150 mg or 500 mg of capecitabine taken orally twice a day at the dose of 1250 mg/m2/dose, until a discontinuation criterion is met

Drug: Bevacizumab
concentrate for solution for infusion containing 25mg/ml of bevacizumab administered intravenously at the dose of 7.5 mg/kg, until a discontinuation criterion is met




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to 12 months. ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 12 months. ]
  2. Duration of Response (DR) [ Time Frame: Up to 12 months. ]
  3. Disease control rate (DCR) [ Time Frame: Up to 12 months. ]
  4. Overall Survival (OS) [ Time Frame: Up to 2 years. ]
  5. Safety and tolerability assessed by incidence of Adverse Events [ Time Frame: Up to 12 months. ]
  6. Safety and tolerability assessed by laboratory tests [ Time Frame: Up to 12 months. ]
  7. Safety and tolerability assessed by physical examination [ Time Frame: Up to 12 months. ]
  8. Safety and tolerability assessed by performance status (ECOG) [ Time Frame: Up to 12 months. ]
  9. Safety and tolerability assessed by vital signs [ Time Frame: Up to 12 months. ]
  10. Safety and tolerability assessed by 12-leads ECG parameters [ Time Frame: Up to 12 months. ]
  11. Quality of Life assessed by a quality of life questionnaire. [ Time Frame: Up to 12 months. ]

Other Outcome Measures:
  1. Circulating protein biomarkers analysis [ Time Frame: through study completion, an average of 12 months ]
    Samples collected at C1D1 (day 1 of cycle 1) and at withdrawal will be subjected to Dproteomic analysis for identification of potential predictive and resistance biomarkers for S 95005 and/or bevacizumab response or biological activity in comparison to capecitabine + bevacizumab arm. Biomarkers in relation to the metabolic pathway of S 95005 and capecitabine will be assessed.

  2. Circulating tumour DNA analysis [ Time Frame: day 1 of cycle 1 (each cycle is 28 days) ]
    Samples collected at C1D1 will be subjected to genomic analysis to study mutations currently observed in colorectal cancer

  3. Proteomic analysis on archived biopsy [ Time Frame: day 1 of cycle 1 (each cycle is 28 days) ]
    Archived biopsy collected at metastatic stage diagnosis, will be recovered at C1D1 and subjected to proteomic analysis in relation to the metabolic pathway of S 95005 and capecitabine for identification of biomarkers that may predict response to S 95005 and capecitabine in combination with bevacizumab

  4. Genomic analysis on archived biopsy [ Time Frame: day 1 of cycle 1 (each cycle is 28 days) ]
    Archived biopsy collected at metastatic stage diagnosis, will be recovered at C1D1 and subjected to microsatellite instability analysis for identification of biomarkers that may predict response to S 95005 and capecitabine in combination with bevacizumab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained.
  • Male or Female participant aged ≥18 years old.
  • Has ECOG 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.
  • Is willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria:

  • Foreseeable poor compliance to the study procedures.
  • Is a pregnant or lactating female.
  • Is inappropriate for entry into this study in the judgment of the Investigator.
  • Has certain serious illness or serious medical condition(s) 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 S 95005 or history of allergic reactions attributed to compounds of similar composition to S 95005 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.

Information from the National Library of Medicine

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


  Show 51 Study Locations
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
Principal Investigator: Eric Van Custem, Prof Leuven Cancer Institute, University Hospitals Leuven

Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02743221     History of Changes
Other Study ID Numbers: CL2-95005-002
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
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 Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
metastatic
colorectal
cancer
untreated
first-line
S95005
bevacizumab
capecitabine

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Capecitabine
Trifluridine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents