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Debio 0123 + Temozolomide for Glioblastoma
Phase 1 & 2
Recruiting
Research Sponsored by Debiopharm International SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to end of study (approximately 54 months)
Awards & highlights
Study Summary
This trial aims to find the safest and most effective dose of Debio 0123 with TMZ and/or radiotherapy to treat glioblastoma in adults.
Who is the study for?
Adults with recurrent or newly diagnosed glioblastoma who've had limited prior treatments can join this trial. They must have a performance status indicating they're mostly independent, stable minor symptoms like seizures, and their major organs should be functioning well. Participants need to commit to the study schedule and agree to use effective birth control.Check my eligibility
What is being tested?
The trial is testing Debio 0123 in combination with Temozolomide (TMZ), both alone and alongside radiotherapy for glioblastoma patients. Phase 1 determines the safest dose while Phase 2 compares its effectiveness against standard care.See study design
What are the potential side effects?
Potential side effects of Debio 0123 are not specified but may include typical reactions related to chemotherapy such as nausea, fatigue, blood cell count changes, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to end of study (approximately 54 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of study (approximately 54 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Change From Baseline in Karnofsky Performance Status (KPS) Score
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Phase 1: Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)
+2 moreSecondary outcome measures
Phase 1: Plasma Concentration of Temozolomide
Phase 2: Change From Baseline in KPS Score
Phase 2: Number of Participants With At Least One TEAE
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2: Debio 0123 RP2D + TemozolomideExperimental Treatment2 Interventions
Participants will receive Debio 0123 RP2D along with TMZ in each 28-day cycle for up to 2 years.
Group II: Phase 1: Arm B - Debio 0123 + Temozolomide + RadiotherapyExperimental Treatment3 Interventions
Participants will receive Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks.
Group III: Phase 1: Arm A - Debio 0123 + TemozolomideExperimental Treatment2 Interventions
Participants will receive Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Debiopharm International SALead Sponsor
50 Previous Clinical Trials
7,061 Total Patients Enrolled
Study DirectorStudy DirectorDebiopharm International SA
1,211 Previous Clinical Trials
489,152 Total Patients Enrolled
1 Trials studying Glioblastoma
116 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been frequently exposed to a lot of sunlight.I have never been treated with a WEE1 inhibitor.I have had a condition where my lymphocytes grow abnormally.I have been treated with medications targeting blood vessel growth in cancer.I have not had radiation in the same area where I would receive it now.My seizures are under control with stable medication.I have had only one treatment for my Grade 4 GBM, IDH-wildtype cancer.I haven't had cancer in the last 5 years, except for skin cancer.I have a history of cancer.I am not allergic to Debio 0123, TMZ, dacarbazine, or their ingredients.I am mostly able to take care of myself.I have had treatments like radiation or chemotherapy for brain cancer.I am willing to provide a tumor sample if I have one.My diagnosis is Grade 4 GBM, IDH-wildtype, confirmed by tissue analysis.I stopped taking TMZ due to a blood-related issue during my combined chemo and radiation therapy.I've been on a stable or reducing dose of corticosteroids for the last week.I haven't had chemotherapy, biologics, experimental treatments, or radiation aimed at curing my condition in the last 28 days.My liver, kidneys, and bone marrow are working well.I am willing and able to follow the study's schedule and procedures.My brain tumor can be measured by MRI according to specific criteria.My diagnosis is either GBM IDH-wildtype Grade 4 or Astrocytoma IDH-mutant Grade 3.I have a confirmed diagnosis of Grade 4 GBM, IDH-wildtype.I've had over 2 treatments for a specific brain cancer type.I haven't needed active treatment for another cancer, except for certain low-risk types, in the last 2 years.I cannot have MRI scans with contrast due to allergies or other reasons.I am 18 years old or older.I can care for myself but may need occasional assistance.I've had up to 1 or 2 treatments, starting with TMZ and radiation.My cancer has returned or worsened, confirmed by a biopsy or brain MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2: Debio 0123 RP2D + Temozolomide
- Group 2: Phase 1: Arm A - Debio 0123 + Temozolomide
- Group 3: Phase 1: Arm B - Debio 0123 + Temozolomide + Radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any spots available for enrolment in this research project?
"This clinical trial, which was initially posted on March 1st 2023 and last revised on the 9th of that same month, is no longer searching for participants. Nevertheless, there are 475 other medical studies currently recruiting patients at this time."
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