Clinical Trials Using PI3K Inhibitor GDC-0084

Clinical trials are research studies that involve people. The clinical trials on this list are studying PI3K Inhibitor GDC-0084. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-4 of 4
  • Safety, Pharmacokinetics and Efficacy of GDC-0084 in Newly-diagnosed Glioblastoma Multiforme

    This protocol has a 2-part design: The phase 2a study component is an open-label, multicenter, phase 2a dose-escalation and expansion study to assess the safety, tolerability, recommended phase 2 dose (RP2D), pharmacokinetics (PK) and clinical activity of GDC-0084 in patients with newly-diagnosed glioblastoma multiforme (GBM) with unmethylated MGMT promoter status as adjuvant therapy following surgical resection and initial chemoradiation with temozolomide (TMZ). The phase 2a study is fully detailed in this submission. The phase 2b study component comprises an evaluation of clinical activity of GDC-0084 compared to TMZ in as adjuvant therapy following surgical resection and initial chemoradiation with TMZ and will be initiated following the determination of RP2D in the phase 2a study (Part 1). The phase 2b component will be will be further detailed in an amendment to this submission.
    Location: 5 locations

  • GDC-0084 and Trastuzumab in Treating Patients with HER2 Positive Breast Cancer Brain Metastases

    This phase II trial studies how well PI3K inhibitor GDC-0084 (GDC-0084) in combination with trastuzumab works in treating patients with HER2 positive breast cancer that has spread to the brain. GDC-0084 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of breast cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body’s immune system. It is not yet known how a HER2-positive breast cancer that has spread to the brain responds to combination of GDC-0084 and trastuzumab.
    Location: 2 locations

  • Genetic Testing in Guiding Treatment for Patients with Brain Metastases

    This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.
    Location: Alliance for Clinical Trials in Oncology, Boston, Massachusetts

  • GDC-0084 after Radiation Therapy in Treating Pediatric Patients with Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Glioma

    This phase I trial studies the side effects and best dose of GDC-0084 when given after radiation therapy in treating pediatric patients with newly diagnosed diffuse intrinsic pontine glioma or diffuse midline glioma. GDC-0084 may stop the growth of tumor cells by reducing the levels of certain proteins needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. It is not yet known whether giving GDC-0084 after radiation therapy may work better in treating patients with diffuse intrinsic pontine glioma or diffuse midline glioma.
    Location: St. Jude Children's Research Hospital, Memphis, Tennessee