INCB7839 for Brain Cancer in Children

Recruiting at 17 trial locations

Overseen By Nina Butingan, MBS

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pediatric Brain Tumor Consortium

Must not be taking: Anticancer, Investigational, Cannabinoids

Disqualifiers: Pregnancy, Breast-feeding, Hypertension, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per course

13 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests INCB7839, a drug that blocks proteins helping cancer cells grow, on children with tough-to-treat brain tumors that have returned or grown after initial treatment. The drug works by stopping a protein needed for tumor growth from being released.

Research Team

Michelle Monje, MD, PhD

Principal Investigator

Stanford University and Lucile Packard Children's Hospital

Eligibility Criteria

This trial is for children aged 3-21 with recurrent or progressive high-grade brain tumors who can swallow pills. They must have measurable disease, be recovered from prior treatments, and have stable health conditions. Those with controlled seizures or neurological deficits may qualify. Patients on birth control and HIV-positive individuals under certain criteria are also eligible.

Inclusion Criteria

I haven't taken any growth factor medications for over a week.

I have tried at least one cancer treatment other than surgery and it didn't work.

My brain tumor is aggressive and has come back or gotten worse.

Exclusion Criteria

My close family has a history of blood clots.

You are pregnant or breastfeeding.

I have not had significant new brain bleeding shown on an MRI in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB7839 for 28 consecutive days per course, with up to 26 courses (approximately 2 years) possible

28 days per course

Regular visits for dose administration and monitoring

Pharmacokinetic Studies

Pharmacokinetic studies performed after oral INCB7839 dose on days 1, 2, and 3 of Course 1

3 days

Daily visits for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days post treatment

Treatment Details

Interventions

• INCB7839

Trial Overview The trial tests INCB7839 in children with high-grade gliomas that came back or got worse after initial treatment. It's a phase 1 study to see how safe the drug is and how it affects these types of brain tumors.

Participant Groups

Group I: Dose-finding Experimental Treatment 1 Intervention

INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2. The INCB7839 dose may be decreased to 80 mg/m2/dose BID if the staring dose is not tolerable. 28 consecutive days (4 weeks) will constitute one course. Patients may continue to receive INCB7839 for 26 courses (approximately 2 years).

Who Is Running the Clinical Trial?

Pediatric Brain Tumor Consortium

Lead Sponsor

Trials

38

Recruited

1,600+

American Lebanese Syrian Associated Charities (ALSAC)

Collaborator

Trials

9

Recruited

670+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

American Lebanese Syrian Associated Charities

Collaborator

Trials

9

Recruited

670+