GliomaEarly Phase 1NCT05061251
Surgical Window of Opportunity Study of Orally Administered BAY 2402234 in Recurrent Glioma
A Early Phase 1 study testing BAY 2402234 in people with Glioma and IDH Mutation, run by University of Texas Southwestern Medical Center.
Trial summary
This study aims to look at how BAY 2402234 responds in body in patients with recurrent glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, IDH Mutation
- What is being tested?
- BAY 2402234
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age
- Histologically and/or genomically documented recurrent or progressive astrocytoma, IDH-mutant, grade 3 or 4 (diagnosis established by the presence of an IDH1 or IDH2 mutation along with grade 3 or 4 radiographic findings)
- Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to dosing, or surgical confirmation of recurrent disease
- Performance status measured via Karnofsky Performance Score of ≥ 60
- Confirmed measurable disease per response assessment in neuro-oncology criteria (RANO)
- Participants should have at least one 1.5cm x 1.5cm region of enhancing and non-enhancing tumor within the surgically accessible region
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- Ability of neurosurgeon to resect tumor
- Laboratory values at the Screening Visit:
- ANC count ≥1,500/mm3;
- Platelets ≥150,000/mm3;
- Hemoglobin > 9g/dL
- Total bilirubin ≤1.5 × the upper limit of normal (ULN) (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits)
- Aspartate aminotransferase (AST [SGOT]) ≤3× the ULN
- Alanine aminotransferase (ALT [SGPT]) ≤3 × the ULN
- Serum creatinine ≤1.5 mg/dL or a calculated creatinine clearance ≤60 mL/min
- Negative serum B-hCG test in women of childbearing potential (defined as women ≤50 years of age, or >50 years of age with a history of amenorrhea for ≤12 months prior to study entry)
- All men, as well as women of child-bearing potential must agree to use dual contraceptive methods (hormonal or barrier method of birth control; abstinence) while on the study drug and for 3 months afterward. Men must also refrain from sperm donation for 4 months after treatment with BAY 2402234. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Patients under age 18 (due to fundamental difference between pediatric and adult gliomas)
- Treatment with an IDH inhibitor within 90 days of enrollment
- Treatment with temozolomide less than 23 days from study initiation, treatment with CCNU or BCNU less than 42 days from study initiation, or treatment with any cancer-directed systemic therapy less than 4 weeks or 5 half-lives from study initiation, whichever is shorter
- Any immunomodulatory drug or molecularly targeted, monoclonal antibody, within 14 days prior to initiation of study drug
- Use of any investigational agents within 28 days of baseline or 5 half-lives from study initiation, whichever is shorter
- Increasing corticosteroid requirement or a dose of >24mg per day of dexamethasone or an equivalent dose of other corticosteroids for longer than 48 hours within 7 days prior to study initiation
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- Radiotherapy within 12 weeks prior to registration unless surgical confirmation of recurrent disease
- Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia or lymphopenia, that has not resolved to ≤ Grade 1, as determined by National Cancer Institute CTCAE v5.0
- Major surgery within 28 days prior to initiation of study drug
- Active or clinically unstable bacterial, viral, or fungal infection requiring systemic therapy
- Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness
- Any of the following within 6 months prior to initiation of study drug: uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary or peripheral artery bypass graft surgery, transient ischemic attack
- Pulmonary embolism within 1 month prior to initiation of study drug
- Unstable cardiac dysrhythmias or persistent prolongation of the QTc interval to >450 msec for males or >470 msec for females
- Any contraindication to contrast-enhanced MRI examination
- Evidence of clinically significant intracranial hemorrhage
- Previous history of an additional emergency, except for non-squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry
- Requires anti-seizure medications that are known to be strong inducers of CYP3A4/5 enzymes (carbamazepine, phenobarbital, phenytoin). Strong inhibitors and/or strong inducers of CYP3A4 should not be administered within 14 days or 5 half-lives (whichever is shorter) of the start of BAY 2402234 treatment, or during BAY 2402234 treatment, unless there is an emergent or life-threatening medical condition
- Pregnant or lactating female
- Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the subject inappropriate for entry into this study
- Difficulty swallowing or malabsorption syndrome; refractory nausea \& vomiting, chronic gastrointestinal disease or previous significant bowel resection with clinically significant sequelae that would preclude adequate absorption of study drug
About this study
Official title: An Open-Label Surgical Window of Opportunity Study Evaluating Pharmacodynamic Response of Orally Administered BAY 2402234 in Subjects With Recurrent Glioma, IDH Mutant, Grade 3 or 4
This study aims to look at how BAY 2402234 responds in body in patients with recurrent glioma.
Read the detailed description
To characterize the biological activity of BAY 2402234 in recurrent glioma, IDH-mutant, Grade 3/4 using liquid chromatography-mass spectrometry (LC-MS). The tissue orotate:carbamoyl aspartate ratio will serve as the primary pharmacodynamic biomarker and will be characterized via LC-MS.
- Conditions
- Glioma, IDH Mutation
- Being tested
- BAY 2402234
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 2402234Drug
Patients will receive 3 doses of 5mg each of BAY 2402234. Drug will be given Day 1 and Day 2 prior to standard-of-care craniotomy for tumor resection and 1 dose on the morning of surgery.
| Study group | Role | What they receive |
|---|---|---|
| BAY 2402234 | Experimental | Patients will receive 1 dose (5mg) orally, per day of BAY 2402234 for the 2 days prior to standard-of-care craniotomy for tumor resection and 1 dose on the morning of surgery, for a total of 3 administered doses. Receives: Drug: BAY 2402234 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological activity of BAY 2402234
The primary endpoint is to characterize the biological activity of BAY 2402234 using liquid chromatography-mass spectrometry (LC-MS). The tissue orotate:carbamoyl aspartate ratio will serve as the primary pharmacodynamic biomarker and will be characterized via LC-MS.
Measured: 3 days up tp day of surgery
Secondary outcomes (1)
Adverse Event Monitoring
To monitor adverse events during treatment with BAY 2402234 and document them in accordance with the Common Technology Criteria for Adverse Events (CTCAE) Version 5.
Measured: 28 days after the final administered dose of BAY 2402234
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Drug availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Kalil Abdullah, University of Texas Southwestern Medical Center
- Investigators
- Kalil g Abdullah, MD, MSc, Principal investigator, UT Southwestern/ Simmons CC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061251
- Sponsor's protocol ID
- BAY 2402234
- Status last verified
- Dec 2021
- First submitted
- 20 Sep 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Surgical Window of Opportunity Study Evaluating Pharmacodynamic Response of Orally Administered BAY 2402234 in Subjects With Recurrent Glioma, IDH Mutant, Grade 3 or 4
- ClinicalTrials.gov ID
- NCT05061251
- Acronym / sponsor ID
- BAY 2402234
- Conditions
- Glioma, IDH Mutation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to look at how BAY 2402234 responds in body in patients with recurrent glioma.
Detailed description
To characterize the biological activity of BAY 2402234 in recurrent glioma, IDH-mutant, Grade 3/4 using liquid chromatography-mass spectrometry (LC-MS). The tissue orotate:carbamoyl aspartate ratio will serve as the primary pharmacodynamic biomarker and will be characterized via LC-MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY 2402234 | Experimental | Drug: BAY 2402234Patients will receive 1 dose (5mg) orally, per day of BAY 2402234 for the 2 days prior to standard-of-care craniotomy for tumor resection and 1 dose on the morning of surgery, for a total of 3 administered doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adults ≥ 18 years of age
- Histologically and/or genomically documented recurrent or progressive astrocytoma, IDH-mutant, grade 3 or 4 (diagnosis established by the presence of an IDH1 or IDH2 mutation along with grade 3 or 4 radiographic findings)
- Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to dosing, or surgical confirmation of recurrent disease
- Performance status measured via Karnofsky Performance Score of ≥ 60
- Confirmed measurable disease per response assessment in neuro-oncology criteria (RANO)
Key exclusion criteria (21 listed)
- Patients under age 18 (due to fundamental difference between pediatric and adult gliomas)
- Treatment with an IDH inhibitor within 90 days of enrollment
- Treatment with temozolomide less than 23 days from study initiation, treatment with CCNU or BCNU less than 42 days from study initiation, or treatment with any cancer-directed systemic therapy less than 4 weeks or 5 half-lives from study initiation, whichever is shorter
- Any immunomodulatory drug or molecularly targeted, monoclonal antibody, within 14 days prior to initiation of study drug
- Use of any investigational agents within 28 days of baseline or 5 half-lives from study initiation, whichever is shorter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY 2402234Patients will receive 3 doses of 5mg each of BAY 2402234. Drug will be given Day 1 and Day 2 prior to standard-of-care craniotomy for tumor resection and 1 dose on the morning of surgery. | Drug | BAY 2402234 |
Primary outcome
Biological activity of BAY 2402234
Time frame: 3 days up tp day of surgery
The primary endpoint is to characterize the biological activity of BAY 2402234 using liquid chromatography-mass spectrometry (LC-MS). The tissue orotate:carbamoyl aspartate ratio will serve as the primary pharmacodynamic biomarker and will be characterized via LC-MS.
1 secondary outcome
Adverse Event Monitoring
Time frame: 28 days after the final administered dose of BAY 2402234
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalil g Abdullah, MD, MSc principal investigator
UT Southwestern/ Simmons CC
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BAY 2402234 in people with Glioma and IDH Mutation, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological activity of BAY 2402234 (time frame: 3 days up tp day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.