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Home » Find Clinical Trials » 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)

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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Servier Protocol Code: CL2-95005-002 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02743221 EudraCT Number: 2015-004544-18

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 57 locations

Study description

The study drug is called S95005 (trifluridine + tipiracil). It is approved to treat patients with colorectal cancer that has spread to other parts of the body when standard treatments are no longer effective. Colorectal cancer that has spread to other parts of the body is called metastatic colorectal cancer.

In this study, the medicine S95005 is combined with another marketed drug called bevacizumab.

Capecitabine with bevacizumab is a treatment recommended in participants with metastatic colorectal cancer.

  • S95005 is a drug that blocks the growth of cancer cells.
  • Bevacizumab is a drug that blocks the blood vessels that provide blood to the tumor. It slows the growth of the tumor.
  • Capecitabine is a drug that also blocks the growth of cancer cells.

This study is called a Phase 2 study. The main objective of the TASCO1 study was to explore the effect of the combination of S95005 with bevacizumab. Another combination (capecitabine with bevacizumab) served as reference.

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).
Results
English (USA)
English (USA)
Conditions
Metastatic Colorectal Cancer
Interventions / Treatments
  • Trifluridine/tipiracil + bevacizumab
  • Capecitabine + bevacizumab
Other study id numbers
  • CL2-95005-002

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be 18 years of age or older.
  • Have been diagnosed with metastatic colorectal cancer.
  • Be too frail to tolerate other therapies.

Participants could not take part in the study if they:

  • Had received treatment for their cancer with radiation or S95005 or similar medicines before starting the study.
  • Had major surgery within 4 weeks before starting the study.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Trifluridine/tipiracil + bevacizumab

Participants took the study drug orally twice daily, for 10 days over 28 day-cycles. They also received bevacizumab into a vein every 2 weeks.

Intervention / Treatment
Drug: Trifluridine/tipiracil + bevacizumab
Participant Group / Arm
Active Comparator: Capecitabine + bevacizumab

Participants took capecitabine orally twice daily, for 14 days over 21 day-cycles. They also received bevacizumab into a vein every 3 weeks.

Intervention / Treatment
Drug: Capecitabine + bevacizumab

Keywords

Provided by Servier
metastatic colorectal cancer untreated first-line S95005 (Trifluridine/tipiracil) bevacizumab capecitabine
Additional Relevant MeSH Terms Glioma
Colorectal Neoplasms Neoplasm Metastasis Neoplasms