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 5 August 2020
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 on5 August 2020

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
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

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
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.