BridgeMD
New treatment option for Glioma
Official title Sitagliptin in Recurrent/Progressive Grade 4 Glioma
ClinicalTrials.gov ID: NCT07541781
What this study is testing
What is Sitagliptin?
Sitagliptin is an investigational medicine, being studied as a potential treatment for glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or progressed after treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give when combined with bevacizumab.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase 1b
- people must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is...
- people must not have received sitagliptin or bevacizumab for this disease.
- Age \>18 years
- Performance status: ECOG performance status 0-2
You likely can't join if
- (for phase 1b and pilot phase)
- Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except for alopecia and neuropathy.
- people receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin or bevacizumab.
- people with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure...
- Known HIV-positive people on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with...
See the full eligibility criteria
Who can join
- Phase 1b
- people must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is diagnosed by the treating physician.
- people must not have received sitagliptin or bevacizumab for this disease.
- Age \>18 years
- Performance status: ECOG performance status 0-2
- people must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
- Hemoglobin ≥ 9 g/dl
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count ≥ 100,000/mcL
- Total bilirubin \< 1.5 x institutional upper limit of normal (ULN)
- AST (SGOT) ≤ 3 X institutional ULN
- ALT (SGPT) ≤ 3 X institutional ULN
- Calculated creatinine clearance \> 50 mL/min
- Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio. For UPC ratio \> 0.5, 24-hour urine protein must be obtained and must be \< 1000 mg.
- Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
- people must have the ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of...
- people must be able to swallow whole tablets.
- Participants must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy
- Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study treatment
- people must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1 Day 1:
- surgery - 4 weeks
- nitrosoureas - 6 weeks
- cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose...
- For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.
- Investigational therapy or non-cytotoxic GBM related therapy - 2 weeks
- Subject is not deemed as a surgical candidate. Pilot Phase
- people must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is diagnosed by the treating physician.
- people must not have received sitagliptin or bevacizumab for this disease.
- Age \>18 years
- Performance status: ECOG performance status 0-2
- people must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
- Hemoglobin ≥ 9 g/dl
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count ≥ 100,000/mcL
- Total bilirubin \< 1.5 x institutional upper limit of normal (ULN)
- AST (SGOT) ≤ 3 X institutional ULN Version date: 30March2026 Page 16
- ALT (SGPT) ≤ 3 X institutional ULN
- Calculated creatinine clearance \> 50 mL/min
- Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio. For UPC ratio \> 0.5, 24-hour urine protein must be obtained and must be \< 1000 mg.
- Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
- people must have the ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of...
- people must be able to swallow whole tablets.
- people must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy
- Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to treatment start
- people must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1Day1:
- surgery - 4 weeks
- nitrosoureas - 6 weeks
- cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose...
- For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.
- Investigational therapy or GBM related non-cytotoxic therapy - 2 weeks
- For bevacizumab (if for a different cancer) - 4 weeks from the expected date of protocol surgery
- Subject is deemed as a surgical candidate.
What rules you out
- (for phase 1b and pilot phase)
- Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except for alopecia and neuropathy.
- people receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin or bevacizumab.
- people with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social...
- Known HIV-positive people on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sitagliptin and/or bevacizumab. In addition, these people are at increased...
- Other malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or vulva; c) prostate cancer of...
- Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version...
- Known active infection with hepatitis B or hepatitis C virus.
- Pregnant or breastfeeding.
- people who receive insulin or sulfonylurea for diabetes mellitus.
- people with history of type 1 diabetes, uncontrolled type 2 diabetes, hypoglycemia requiring medical intervention, or those who are deemed not suitable to receive sitagliptin at the discretion of the investigators.
- Unable or unwilling to swallow tablets.
- Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator's judgment, make the patient inappropriate for this study.
- Arterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study consent.
- people with history of hematologic bleeding disorder.
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.