Sitagliptin in Recurrent/Progressive Grade 4 Glioma

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Kailin Yang, MD, PhD
Study ID
NCT07541781
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sitagliptin — DRUG
    Sitagliptin, PO dose to be determined by Phase I dose de-escalation, cycle length 28 days. Treatment until progression.
  • Bevacizumab — BIOLOGICAL
    Bevacizumab, IV, 10 mg/kg days 1 and 15 every 28 days, until progression.

Study Details

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 Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 1, 2029
Completion
May 1, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Standard of care Bevacizumab in addition to Sitagliptin
    Phase I: Bevacizumab in combination with Sitagliptin Phase Ib: a standard 3+3 design and dose de-escalation will be used to determine the maximal tolerated dose (MTD) of sitagliptin in combination with bevacizumab on non-surgical patients with recurrent GBM Pilot: 12 patients with recurrent GBM, will receive pre-operative treatment with sitagliptin for at least 5 days at the MTD determined in phase 1b. These patients will then undergo surgical resection of the tumor. All patients will receive postoperative sitagliptin in addition to standard-of-care bevacizumab

Primary Outcome Measure

Phase Ib: Dose-limiting toxicities as measured by CTCAE v5.0 [ Time Frame: First day of treatment through completion of cycle 2 of therapy (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Kailin Yang, MD, PhD
[email protected]
+1 319 356 3630
Kailin Yang, MD, PhD (PRINCIPAL_INVESTIGATOR)

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