Sitagliptin in Recurrent/Progressive Grade 4 Glioma

Recruiting now · Phase 1

Conditions studied: Glioma, Glioblastoma, Recurrent Glioma, Recurrent Glioblastoma, Grade 4 Malignant Glioma of Brain (Disorder)

In brief

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.

Key facts

Study ID

NCT07541781

Run by

Kailin Yang, MD, PhD

People needed

45

Starts

2026-06-11

Expected to finish

2030-06-11

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase 1b
• Subjects 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.
• Subjects must not have received sitagliptin or bevacizumab for this disease.
• Age >18 years
• Performance status: ECOG performance status 0-2
• Subjects 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
• Subjects 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 spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days prior to treatment start. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.
• Subjects 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
• Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1 Day 1:
• surgery - 4 weeks

Where it is running

• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.