A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors|
- Incidence of Dose limiting toxicities [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE).
- Incidence and severity of adverse events and serious adverse events, changes in laboratory values [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
- Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite. [ Time Frame: 2 months ] [ Designated as safety issue: No ]Plasma concentration of MEK162 and active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite will be measured with serial plasma samples during treatment for first 2 months.
- Tumor responses according to RECIST 1.1 [ Time Frame: 4 months ] [ Designated as safety issue: No ]Tumor responses will be measured according to RECIST 1.1
- Levels of p-ERK in tumor and skin [ Time Frame: 4 months ] [ Designated as safety issue: No ]Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies.
The prescribed BID doses should be taken 12 ± 2 hrs apart.
MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469130
|Novartis Investigative Site|
|Nagoya-city, Aichi, Japan, 466-8560|
|Novartis Investigative Site|
|Yufu, Oita, Japan, 879-5593|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|