Melanoma Clinical Trial
Official title:
Phase II Clinical Trial of the MEK Inhibitor Trametinib With the AKT Inhibitor GSK2141795 in BRAF Wild-type Melanoma
This is a multicenter phase II clinical study of trametinib in combination with GSK2141795 in
patients with BRAF wild-type mutation melanoma. All patients will receive continuous dosing
of trametinib (2 mg) in combination with GSK2141795 (25 mg) oral daily until progression of
disease, withdrawal of consent, or the development of intolerable treatment associated
toxicity. Imaging (CT or MRI) will be performed within 7 days prior to day 1 of Odd Cycles,
starting with Cycle 3.
Patients may continue treatment with trametinib in combination with GSK2141795 on trial until
disease progression or the development of unacceptable toxicity that does not improve with
maximal supportive care or dose reduction per protocol.
Treatment-associated adverse events will be assessed based on clinical and laboratory
findings using the Common Toxicity Criteria for Adverse Events, version 4.0. Adverse event
(AE) assessments will be performed every week through cycle 3 day 1, and on day 1 for every
cycle thereafter. AEs and Serious adverse events (SAE)s will be monitored by UCSF's Data
Safety Monitoring Committee.
Safety assessments will include medical history, physical examination, Complete Blood Count
(CBC) with differential, chemistries panel, thyroid function and pregnancy tests, ECGs, and
ophthalmology evaluations. Screening assessments will also include a transthoracic
echocardiogram or multiple-gated acquisition (MUGA) scan, and brain imaging.
It is estimated that 48 patients will complete the study.
n/a
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