A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade … (NCT04458272) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
Japan25 participantsStarted 2020-07-08
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial studying DS-1001b specifically in patients with IDH1-mutated WHO Grade II glioma who haven't yet had chemotherapy or radiation, can you confirm whether my tumor has been tested for the IDH1 mutation, and does my diagnosis fit that profile?
2This trial is 'active but not recruiting,' which means it's no longer enrolling new patients — are there any other trials studying DS-1001b or similar IDH1-targeted treatments that I might still be eligible to join?
3The trial is measuring 'overall response rate,' meaning how many patients' tumors shrink or respond to the drug — given that we're still waiting on those results, how does that uncertainty about benefit compare to starting standard treatments like chemotherapy or radiation now?
4Because this trial was designed for patients who haven't yet received chemotherapy or radiation, would enrolling in it — or a similar study — mean delaying those proven treatments, and what are the risks of that delay for my specific situation?
5The trial is also tracking treatment-related side effects as a primary goal, which suggests the safety profile of DS-1001b is still being established — what is currently known about the risks of this drug, and how would that factor into your recommendation for my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
Timeframe: Up to 24 months
2
Number of participants with treatment-emergent adverse events (TEAEs) during the study