Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations

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This is a 3-part (Part A, Part B, Part C), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors. Part A is a repeat dose, dose escalation monotherapy study that will identify the recommended phase II dose (RP2D) on the continuous dosing schedule using a… Read more »

RTA 408 Capsules in Patients With Melanoma – REVEAL

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Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths. For metastatic or unresectable melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab and nivolumab) and other therapies, however, approved therapies are rarely curative. It is now well accepted… Read more »

Ipilimumab With or Without Dabrafenib, and/or Trametinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery

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This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib and/or trametinib in treating patients with melanoma that is metastatic or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the… Read more »

BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer

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This is an open-label, three-part Phase 1/2 study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of trametinib (GSK1120212) and dabrafenib (GSK2118436) when administered in combination with the anti-EGFR antibody panitumumab in subjects with BRAF-mutation V600E or V600K positive colorectal cancer (CRC). Part 1 of the study will consist… Read more »

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

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This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell tumor/non-geminomatous germ cell tumor, hairy cell leukemia, World Health Organization (WHO) Grade 1 or 2… Read more »

The Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Pediatric Subjects

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This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral dabrafenib in pediatric subjects with advanced BRAF V600 mutation-positive solid tumors. Part 1 (dose escalation study) will identify the recommended Part 2 (tumor-specific expansion study) dose and regimen using a dose-escalation procedure. Approximately 6 to 18… Read more »