Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 12, 2022
  • participants needed
    490
  • sponsor
    Taiho Oncology, Inc.
Updated on 12 August 2021

Summary

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

Description

This is an international, open-label, controlled two-arm, randomised phase III study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC. The analysis will be done after 331 events are reported. In order to observe this number of events, 490 patients will be randomised (1:1) to receive trifluridine/tipiracil in combination with bevacizumab (experimental arm) or trifluridine/tipiracil monotherapy (control arm).

Details
Condition Refractory Metastatic Colorectal Cancer
Treatment bevacizumab, Trifluridine/Tipiracil
Clinical Study IdentifierNCT04737187
SponsorTaiho Oncology, Inc.
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)
RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy
Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen
Has measurable or non-measurable disease as defined by RECIST version 1.1
Is able to swallow oral tablets
Estimated life expectancy 12 weeks
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

Exclusion Criteria

More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer
Pregnancy, lactating female or possibility of becoming pregnant during the study
Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization
Has not recovered from clinically relevant non-hematologic CTCAE grade 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation)
Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease
Has severe or uncontrolled active acute or chronic infection
Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension
Known Hepatitis B or Hepatitis C Virus infection
Known carriers of HIV antibodies
Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure 150 mm Hg and/or diastolic blood pressure 100 mm Hg) or uncontrolled or symptomatic arrhythmia
Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization
Treatment with any of the following within the specified time frame prior to
randomization
major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only
Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization
Other clinically significant medical conditions
Other malignancies
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note