Combination Study of GSK1120212 With Gemcitabine in Subjects With Solid Tumors
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IB Combination Study of MEK Inhibitor GSK1120212 With Gemcitabine in Subjects With Solid Tumors|
- Adverse events (AEs) and changes in laboratory values and vital signs. [ Time Frame: From date of randomization until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized. ] [ Designated as safety issue: No ]
- Tumor response as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v 1.1 [ Time Frame: At screening and every 8 weeks until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized. ] [ Designated as safety issue: No ]
- drug levels in blood [ Time Frame: first 15 days on study ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Dose escalation to maximum tolerated dose of GSK1120212 and Gemcitabine.
Continuous daily oral dosing while on study or disease progression (cycle = 28 days).Drug: Gemcitabine
Dosing once weekly for 3 weeks in a 28 day cycle until disease progression.
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).
|United States, Tennessee|
|GSK Investigational Site|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|GSK Investigational Site|
|San Antonio, Texas, United States, 78229|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|