Spots Global Cancer Trial Database for Combination Study of GSK1120212 With Gemcitabine in Subjects With Solid Tumors

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Trial Identification

Brief Title: Combination Study of GSK1120212 With Gemcitabine in Subjects With Solid Tumors

Official Title: A Phase IB Combination Study of MEK Inhibitor GSK1120212 With Gemcitabine in Subjects With Solid Tumors

Study ID: NCT01428427

Conditions

Leukaemia, Myelocytic, Acute

Interventions

GSK1120212

Gemcitabine

Study Description

Brief Summary: MEK112111 is a dose-escalation, Phase IB, open-label, single-arm, multi-center study. The primary objective of the study is to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 dosed in combination with gemcitabine in subjects with solid tumors.

Detailed Description: Subjects will be enrolled using a dose-escalation procedure in which the initial cohort receives a fraction of the GSK1120212 dose that achieved a dose limiting toxicity in a previous study and the recommended dose of gemcitabine. Escalation will proceed until the maximum tolerated doses are identified. These doses will be selected based on emerging safety data. Confirmation of the tolerability of the Recommended Phase II Dose (RP2D) will be explored in approximately 12 subjects. Subjects will continue on treatment until treatment discontinuation criteria are met (disease progression, intercurrent illness, adverse event or consent withdrawal).