Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jan 28, 2023
  • participants needed
    30
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 2 February 2022
measurable disease

Summary

This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 30 patients total).

Details
Condition Solid Tumor
Treatment Decitabine, Cedazuridine
Clinical Study IdentifierNCT03875287
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on2 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed
Patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition
ECOG performance status <1
Ability to understand and the willingness to sign a written informed consent document
Patients must have measurable disease
Ability to swallow oral medications

Exclusion Criteria

Participants who have had chemotherapy or radiotherapy within 3 weeks
Participants may not be receiving any other investigational agents
Active hepatitis B or hepatitis C infection
Active or untreated gastric or duodenal ulcer
Symptomatic bowel obstruction within 3 months prior to screening visit
Symptomatic ascites in the last 4 weeks
Other protocol defined inclusion/exclusion criteria may apply
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...

Browse trials for

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