marked.bio

PI3K/mTOR inhibitor · small molecule

paxalisib

3 active trials across 3 of our biomarkers, targeting PI3K/mTOR. Not approved for any biomarker on marked.bio yet.

Also known as GDC-0084.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRAF V600E 2 2 Phase 2
KRAS G12C 1 1 Phase 2
PIK3CA activating mutation 1 1 Phase 1

Trials

3 of 3 trials shown

  1. Combination Therapy for the Treatment of Diffuse Midline Gliomas

    Recruiting Phase 2 University of California, San Francisco Started 2021Primary completion 2027-12 NCT05009992

    ONC201paxalisibDNX-2401

    BRAFV600E

    BRAF V600EDiffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Diffuse Midline Glioma, H3 K27M-Mutant

  2. Genetic Testing in Guiding Treatment for Patients With Brain Metastases

    Active, not recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2019Primary completion 2025-11 NCT03994796

    abemaciclibpaxalisibentrectinibadagrasib FDA EU

    Similarly, for patients with KRAS G12C mutations, MRTX849 may be used for newly diagnosed brain metastases.

    KRAS G12CBRAF V600ECDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, NTRK Family Gene Mutation

  3. GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

    Active, not recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2019Primary completion 2026-12 NCT04192981

    paxalisib

    Histologically confirmed solid tumor malignancies harboring PIK3CA mutations which include mutations in any of the following genes: PIK3CA, PIK3CB, PIK3CD, PIK3CG, PI…

    PIK3CA activating mutationBrain Metastases, Leptomeningeal Metastasis