Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Other Ras/raf/erk Pathway Activated Tumors
  Low Grade Gliomas
• Age: Between 1 years - 17 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  Phase I
  1.  Patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any low-grade gliomas
  2.  Any tumor with a documented activating BRAF, NRAS, or KRAS mutation

  3.  Any tumor in a patient with NF1

  Phase II
  3.  Patients with recurrent or progressive disease as defined in the following:
         Stratum 1:  Patients with low-grade gliomas with a BRAF truncated fusion that is measurable in at least two dimensions on imaging
         Stratum 2:  Patients with NF1 and low grade glioma that is measurable in at least two dimensions of imaging
         Stratum 3:  Pediatric patients with recurrent or progressive tumors thought to involve the Ras/Raf/ERK pathway but not included in strata 1 or 2 that is measurable in at least two dimensions on imaging.
         Stratum 4 (surgical arm; target validation):  Patients who meet criteria for stratum 1, 2, or 3 for whom tumor biopsy and/or resection is clinically indicated.

  4.  Patients must have received at least one prior chemotherapy or radiation regimen prior to progression

  
  

You may not be eligible for this study if the following are true:

• 1.  Patients for whom other curative or established standard-of-care therapeutic options with acceptable morbidity exist.

  2.  Patients with any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.

  3.  Patients with a history of Gilbert's syndrome; history of retinal degenerative disease

  4.  Patients receiving any other anticancer or experimental drug therapy; prior therapy with a MEK inhibitor