Sitagliptin + Bevacizumab for Brain Cancer

Overseen By Kailin Yang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kailin Yang, MD, PhD

Must not be taking: Antiretrovirals, Insulin, Sulfonylureas

Disqualifiers: Uncontrolled illness, Active infection, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kailin Yang, MD, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a woman of childbearing age and have tested negative for pregnancy before treatment.

I am able to swallow whole tablets.

Phase 1b: Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study registration

Exclusion Criteria

I have a history of type 1 diabetes, uncontrolled type 2 diabetes, or severe low blood sugar.

I cannot or do not want to swallow tablets.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Participants receive sitagliptin in combination with bevacizumab to determine the maximal tolerated dose using a 3+3 design and dose de-escalation

56 days

Multiple visits for dose escalation and monitoring

Pilot Phase Treatment

12 patients receive pre-operative treatment with sitagliptin for at least 5 days at the MTD, followed by surgical resection and postoperative sitagliptin with bevacizumab

5 days pre-op + 28 days post-op cycle

Pre-operative and post-operative visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including event-free survival and overall survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab
• Sitagliptin

How Is the Trial Designed?

Group I: Standard of care Bevacizumab in addition to Sitagliptin Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Kailin Yang, MD, PhD

Lead Sponsor