TAC113886: A Phase I Dose Escalation Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study to Determine the Recommended Phase II Dose of GSK1120212 Dosed in Combination with GSK2141795

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TAC113886: A Phase I Dose Escalation Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study to Determine the Recommended Phase II Dose of GSK1120212 Dosed in Combination with GSK2141795

Primary: Part 1A: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination orally, once daily continuously. Part 1B: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination with an alternate schedule (i.e., at least one agent is dosed intermittently). Part 2A, 2B: To evaluate the clinical activity of GSK1120212 and GSK2141795 administered in combination in subjects with solid tumors that are predicted to be sensitive to the inhibition of MEK and/or AKT, including TNBC and BRAF-wild type melanoma.
Secondary: (1) To characterize the PK of GSK1120212 and GSK2141795 for a once daily continuous dosing schedule (Part 1A) and/or an intermittent dosing schedule (Part 1B). (2) Part 1A, Part 1B to evaluate the clinical activity of GSK1120212 and GSK2141795 in subjects with solid tumors. (3) Parts 1 and 2, to characterize the durability of response with GSK1120212 and GSK2141795 dosed orally in combination. (4) To evaluate the pharmacodynamic (PD) response in tumors after treatment with the combination of GSK1120212 and GSK2141795. (5) To explore relationships between study drug PK, PD and clinical activity.
Translational: To explore the association of clinical and PD endpoints with genetic and protein profiles from blood and/or tumor tissue.

Protocol Number051208
Principal InvestigatorAntoinette Tan
PhasePhase I
ScopeNational
Applicable Disease SitesBreast - Female
Any Site
Melanoma, skin
Therapies InvolvedChemotherapy multiple agents systemic
Chemotherapy single agent systemic
Drugs InvolvedGSK2141795
Trametinib
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.