Phase I/II study of dabrafenib trametinib and navitoclax in BRAF mutant melanoma (Phase I and II) and other solid tumors (Phase I only).

Are you eligible to participate in this study?

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

  • Conditions:
    Melanoma
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using validated, commercially available assay performed in a CLIA-approved laboratory) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. 2) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as =20 mm with conventional techniques or as =10 mm with spiral CT scan, MRI, or calipers by clinical exam.

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

  • 1) Patients who have had immunotherapy, chemotherapy or radiotherapy within 14 days prior to the first dose of navitoclax, or prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to first dose of dabrafenib and/or trametinib; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment. 2) Patients who are receiving any other investigational agents have received any other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study.


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