Safusidenib for Brain Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Nuvation Bio Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new oral medication called safusidenib for patients with certain types of brain tumors that have not responded to other treatments. The drug works by targeting a specific gene mutation to slow down tumor growth. The study will evaluate the safety and effectiveness of different doses of the medication.

Eligibility Criteria

Adults over 18 with recurrent or progressive brain tumors (WHO Grade 2/3 glioma) and specific IDH1 mutations can join this trial. They must have had no more than two prior treatments, a measurable lesion, good organ function, and a life expectancy of at least three months. Women must not be able to bear children or use contraception; men should use condoms.

Inclusion Criteria

I have had 2 or fewer treatments for my cancer coming back or getting worse.

Total bilirubin: ≤ 1.5 × ULN

Absolute neutrophil count: ≥ 1,500/μL

+17 more

Exclusion Criteria

Positive test results for human immunodeficiency virus (HIV) antibody.

I do not have psychiatric conditions that could affect my study participation.

I haven't had a heart attack, severe chest pain, heart failure, stroke, or similar issues in the last 6 months.

+11 more

Participant Groups

The study tests different doses of safusidenib, an oral drug for brain tumors with IDH1 mutation. Part 1 assesses safety and initial efficacy in up to 25 patients across five dosage groups. Part 2 evaluates the drug's effectiveness in larger cohorts for each tumor grade.

5Treatment groups

Experimental Treatment

Group I: safusidenib 500mg qdExperimental Treatment1 Intervention

safusidenib 500mg qd administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group II: safusidenib 500mg bidExperimental Treatment1 Intervention

safusidenib 500mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group III: safusidenib 375mg bidExperimental Treatment1 Intervention

safusidenib 375mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group IV: safusidenib 250mg bidExperimental Treatment1 Intervention

safusidenib 250mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.

Group V: safusidenib 125mg bidExperimental Treatment1 Intervention

safusidenib 125mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity.