VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Megan Mantica
Study ID
NCT07629089
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    Oral targeted therapy for IDH1- or IDH2-mutant grade 2 astrocytoma or oligodendroglioma, approved for use after surgery.
  • Lomustine — DRUG
    An alkylating nitrosourea compound used in chemotherapy. It is highly lipid-soluble thus it crosses the blood-brain barrier. Primarily used in treating brain tumors.

Study Details

This study will test the hypothesis that vorasidenib in combination with lomustine will be safe and tolerable. The overall goal of this study is to identify the optimal vorasidenib dose that can be tested in a subsequent phase 2 study to determine the efficacy of vorasidenib in combination with lomustine in patients with recurrent IDH mutant gliomas.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2035

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorasidenib + Lomustine
    Dose Escalation: Dose level 0: (40mg) Vorasidenib + Lomustine 110mg/m\^2 (orally) on day 1 of each 42-day cycle Dose level -1: (20mg) Vorasidenib + Lomustine 110mg/m\^2 (orally) on day 1 of each 42-day cycle Dose level -2: (10mg) Vorasidenib + Lomustine 110mg/m\^2 (orally) on day 1 of each 42-day cycle

Primary Outcome Measure

Recommended Combination Dose (RCD) [ Time Frame: Up to 48 months ]

Central Contacts

Locations (1)

FacilityCityStateZIP
UMPC Hillman Cancer CenterPittsburghPennsylvania15232

Find similar trials in Pittsburgh, PA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
UMPC Hillman Cancer Center· Pittsburgh, PA

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