A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    25
  • sponsor
    Daiichi Sankyo Co., Ltd.
Send
Updated on 19 February 2024
See if I qualify

Summary

This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.

Details
Condition WHO Grade II Glioma
Age 20years - 100years
Treatment DS-1001b
Clinical Study IdentifierNCT04458272
SponsorDaiichi Sankyo Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification
Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory conducted during the screening period
Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy
Has at least 1 measurable and non-enhancing lesion
Has an interval of at least 90 days from the latest surgery
Has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1

Exclusion Criteria

Has had a histopathological diagnosis of WHO grade III or IV glioma
Has had a contrast enhancing lesion on brain MRI
Has received a prior treatment with any mutant IDH1 inhibitor
Has received other investigational products within 28 days before the start of the study drug treatment
Has an active infection requiring systemic treatment
Has multiple primary malignancies
Has a history of clinically significant cardiac disease
Is a pregnant or lactating woman
Clear my responses
Read more

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

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

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

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

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.

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