ACP-196 for Glioblastoma

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Acerta Pharma BV

Must be taking: Anticonvulsants

Must not be taking: Strong CYP3A4 inhibitors

Disqualifiers: Significant cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A Phase 1b/2, Multicenter, Open-Label Study of ACP-196 in Subjects with Recurrent Glioblastoma Multiforme (GBM)

Will I have to stop taking my current medications?

The trial requires that you be on a stable dose of any necessary medication, like anticonvulsants, for at least 3 weeks before starting the study drug. It doesn't specify stopping other medications, but you should discuss your current medications with the study team.

Who Is on the Research Team?

Acerta Clinical Trials

Principal Investigator

1-888-292-9613; [e-mail]

Are You a Good Fit for This Trial?

This trial is for adults over 18 with recurrent Glioblastoma Multiforme (GBM) who've had prior therapy including temozolomide. Participants should have a life expectancy of at least 12 weeks, an ECOG status ≤2, and stable brain disease as seen on MRI. They must not have had more than two systemic therapies for GBM or certain other cancers within the last two years.

Inclusion Criteria

My steroid dose has been stable or decreasing for at least 5 days before my baseline MRI.

I can take care of myself but might not be able to do heavy physical work.

I have finished all my previous cancer treatments before starting ACP-196.

Exclusion Criteria

I have been treated with Avastin before.

Breastfeeding or pregnant

I need treatment with a strong medication that affects liver enzymes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ACP-196 either 200 mg BID or 400 mg QD for recurrent GBM

8 weeks

Visits on Cycle 3 Day 1, Cycle 4 Day 1, and every 8 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACP-196

Trial Overview The study tests ACP-196's effectiveness in treating GBM that has come back after treatment. It's open-label, meaning everyone knows they're getting ACP-196, and it involves multiple centers to gather diverse data.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

ACP-196 400mg administered orally (PO) once per day (QD).

Group II: Cohort 1 Experimental Treatment 1 Intervention

ACP-196 200 mg administered orally (PO) twice per day (BID)

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials

46

Recruited

5,900+