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PLX038 for Brain Tumors

Phase 1 & 2
Recruiting
Led By Marta Penas-Prado, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Karnofsky >= 70%
Must not have
Major surgery within 2 weeks prior to study treatment initiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a drug in people with brain/spinal cord tumors to see if it can help reduce tumor size and improve survival. Eligible participants must be 18 or older; some must have tumors with changes in certain genes.

Who is the study for?
Adults with certain brain or spinal cord tumors, specifically those with changes in MYC or MYCN genes. They must have had previous specific treatments, be able to perform most daily activities (Karnofsky >= 70%), and have proper organ function. Women who can bear children and men must use contraception; breastfeeding women must stop breastfeeding.
What is being tested?
The trial is testing PLX038, a drug for brain/spinal cord tumors with genetic changes. Participants receive PLX038 via IV on day one of each 21-day cycle and self-inject another drug at home after three days to prevent infection. The treatment lasts up to seven months, followed by check-ups for five years.
What are the potential side effects?
Possible side effects of PLX038 are not detailed but may include reactions similar to other drugs in its class. Side effects could involve the immune system, blood counts, liver function, and risk of infection due to the need for additional medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am mostly able to care for myself.
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I am breastfeeding but willing to stop for the trial.
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My brain tumor diagnosis is confirmed by a specific lab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I: To confirm the RP2D of PLX038 in participants with progressive or recurrent primary CNS tumors
Phase II: To assess the efficacy of PLX038 in primary CNS tumors containing MYC or MYCN amplifications
Secondary study objectives
Determine overall survival (OS)
Determine progression free survival (PFS)
Determine the treatment-related toxicities
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase IIExperimental Treatment1 Intervention
RP2D of PLX038
Group II: Phase IExperimental Treatment1 Intervention
Escalating and de-escalating doses of PLX038
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PLX038
2016
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,940 Total Patients Enrolled
Marta Penas-Prado, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
253 Total Patients Enrolled
~80 spots leftby Nov 2028
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