Gilteritinib for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: FLT3 inhibitors, CYP3A inducers

Disqualifiers: Active CNS metastases, Child-Pugh C cirrhosis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 21 days per cycle

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs frequently occur. Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia. However, studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells. Therefore, in this clinical trial, the investigators plan to study the effect of giltertinib in patients with ALK NSCLC.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anti-cancer medications at least 7 days before starting gilteritinib. Additionally, you cannot take certain drugs that affect liver enzymes or specific receptors unless they are absolutely essential for your care.

Research Team

Angel Qin

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

This trial is for adults with stage IV ALK positive non-small cell lung cancer (NSCLC) who have not responded to other treatments. Participants must be able to undergo procedures like biopsies and scans, and complete questionnaires.

Inclusion Criteria

AST (SGOT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases

Ability to understand and sign a written informed consent

Measurable disease per RECIST v1.1 criteria

Exclusion Criteria

I have been treated with a FLT3 inhibitor before.

Mean triplicate screening EKG QTc > 480 ms

I received comfort-focused radiation therapy within the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive gilteritinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

21 days per cycle

Echocardiography, blood sample collection, CT scan, MRI, and potential tumor biopsy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years after last dose

Regular assessments for adverse events and tumor response

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 2 years after last dose

Treatment Details

Interventions

• Gilteritinib

Trial Overview The trial is testing the safety, side effects, and best dose of a drug called gilteritinib. This medication is approved for leukemia but will now be tested in patients with a specific type of resistant lung cancer.

Participant Groups

Group I: Treatment (gilteritinib) Experimental Treatment 7 Interventions

Patients receive gilteritinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography at screening and blood sample collection, CT scan and MRI at screening and on study. Additionally, patients may undergo a tumor biopsy pre-treatment and at end of treatment.

Gilteritinib is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Xospata for:

• Acute myeloid leukemia (AML) with FLT3 mutation

Approved in European Union as Xospata for:

• Acute myeloid leukemia (AML) with FLT3 mutation

Approved in Japan as Xospata for:

• Acute myeloid leukemia (AML) with FLT3 mutation

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+